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新药研发和医疗器械出口

加入医疗领域的国际相互认证协定

韩国以加入医疗领域的多边相互承认协议为契机,将韩国国内医院的临床检查结果与各国医院分享,吸引外国病患赴韩就医、推动韩国医疗机构国际化。

 

韩国技术标准署署长郑东熙表示,为了加入临床检查结果的多边相互承认协议,相关国际机构(APLAC)已经就多边相互承认协议对韩国进行了评价,并于12月1日签署了医疗领域的多边相互承认协议(APLAC-MRA)。

 

 * 亚太实验室认可合作组织: APLAC

 

本协议的签署,增强了韩国医疗机构临床检查结果的可信度,促进外国病患赴韩就医,并为韩国医疗服务的国际化打下基础。

 

-临床检查,作为新药研发和医疗器械出口的必要条件,今后在国内的注册医疗机构里便可以完成,而不必依赖于外国;同时还能降低高昂的检查费用。

 

 * 国外就业人员和留学生曾经需要通过指定医疗机构进行体检,现在也可以通过国内的注册医疗机构进行身体健康检查。

 

韩国从2014年开始进行临床检查室的认证工作,现在包括三星首尔医院在内的6家医疗机构取得了国际注册医疗机构的认证。

 

 * 三星首尔医院,原子能医学院,首尔大医院,首尔牙山医院,全北大医院等6所医疗机构获得认证。

 

临床检查领域的国际注册医疗机构,是指能达到国际标准(ISO 15189)中规定的质量体系和技术水平、检查结果可信度高的医疗机构。

强化聚氨酯跑道有害物质安全标准

-强化25种有害物质安全标准、装置现场检查设施,确保安全-

就目前在聚氨酯跑道中检测出有害物质重金属(钠)超标的问题,韩国技术标准署表示,为确保全体国民能够安全使用跑道,韩国技术标准署已听取业界以及专家的意见,强化有害物质安全标准(2016.12.20)。

 

新标准针对易在人体内沉积并引发重金属中毒的4大重金属(铅Pb,镉Cd,铬Cr+6,水银Hg)的含量做出了规定,标准较外国儿童用产品安全标准更为严格,以便所有学生能够安全进行体育活动。

 

韩国技术标准署决定含有弹性添加剂的产品施工过程中,使用含有重金属的材料(催化剂,颜料等)时,对重金属进行超标检测。并应向全社会普遍反映,在安全标准中增加除以上四种重金属以外的有害物质检测。

 

本次安全标准修正主要内容如下:

①安全标准适用范围由原来的学校体育设施扩大到学校以外的设施。(如公共体育设施,登山道,休闲步道等)

②保留四大重金属原有含量标准,新增重金属项目的标准则达到了欧洲儿童用品安全标准的水平。新增项目有锌、砷、铝等十五种金属元素及6种酞酸盐塑化剂等。

③最后,由于弹性添加剂产品特性,产品现场质量有可能因施工技术而变化,因此为使用者能够进行现场检查(竣工验收),在附属说明书内增加了相关内容,以切断不达标商品的流通。

 

因此,此次韩国产业标准修正,能够确保使用弹性添加剂强聚酯氨的跑道使用更加安全,保障的全国国民的健康安全。

 

另外,韩国技术标准署公布了韩国产业标准KS F 3888-2(室外体育设备弹性添加剂)的修改细节,并在e-国家标准认证网站(www.standard.go.kr)上进行公示。韩国国家标准署表示,将与相关单位合作,尽快正式实施新修订的标准,对弹性添加剂的实际使用作出规范。

 

•酞酸盐塑化剂:

酞酸盐塑化剂是能够增强塑料柔软度的一种化学添加剂,邻苯二甲酸二辛酯(DEHP)是最为常见的一种,能够引发内分泌障碍,广泛应用于化妆品、玩具、家用地板等领域。

常见酞酸盐塑化剂:BBP(邻苯二甲酸酯)、DBP(邻苯二甲酸二丁酯)、DEHP(邻苯二甲酸二辛酯)、DINP(邻苯二甲酸二异壬酯)、DNOP(邻苯二甲酸二正辛酯)、DIDP(邻苯二甲酸二异癸酯)。

 

•有害重金属:

有害重金属进入人体后堆积,会引发重金属中毒。一般将铅、铬、汞、镉、锑、铊、锰、砷等八种元素归为有害重金属,但欧洲还将锌、钴、镍、铜等11种材料划分为有害重金属元素。

常见有害重金属:铅Pb、镉Cd、铬Cr+6、汞Hg、锑Sb、砷As、硒Se、钡Ba、铝Al、硼B、铬Cr+3、钴Co、铜Cu、锰Mn、镍Ni、锶Sr、锡Sn、有机锡化合物锌Zn等十九种。

 

参考1 国内外儿童用品安全管理标准

有害元素溶出量(欧洲、美国、加拿大、澳大利亚)

分类

韩国

欧洲

美国

加拿大

澳大利亚

KS

儿童用品特别法

 

CPSIA

16CFR 1303

ASTMF963-11

Consumer

Product

Safety Act

AS/NZISO

8124

(ISO 8124)

单位

mg/kg

mg/kg

分类1

mg/kg

分类2

mg/kg

分类3

mg/kg

mg/kg

mg/kg

mg/kg

5625

1406

70000

60

45

11.3

560

60

1000

60

25

3.8

0.9

47

25

1000

25

1000

1500

375

18750

1000

1000

1000

1200

300

15000

 

75

1.3

0.3

17

75

1000

75

60

60

60

铬III

37.5

9.4

460

铬VI

0.02

0.005

0.2

10.5

2.6

130

622.5

156

7700

90

13.5

3.4

160

90

90

1200

300

15000

60

7.5

1.9

94

60

60

75

18.8

930

500

37.5

9.4

460

500

1000

500

4500

1125

56000

15000

3750

180000

有机锡

0.9

0.2

12

3750

938

46000

分类1:使用后分散成粉末状的固体材质(如粉笔、蜡笔等)

分类2:有流动性或粘性的材质(如肥皂、手指水彩颜料、胶水等)

分类三:固体材质(例:油漆,橡胶、PVC等)

 

 

有害元素含量

分类

韩国

欧洲

美国

加拿大

KS

KC

90

300(90,覆盖物)

500

100(90,覆盖物)

90,覆盖物

50

75

100

(各州法律不同)

25

 

25

个别规定(玩具)

 

不允许

 

酞酸盐塑化剂总含量

分类

韩国

欧洲

美国

KS

KC

标准值

0.1%

0.1%

0.1%

 

 

DIN ISO 45001 “职业健康安全管理体系—要求及使用指南”计划于2018年年初发布

      ISO 45001“职业健康安全管理体系——要求及使用指南”预计2017年无法出台,国际标准草案第一稿(DIS 1)现在还在修订中。在2015年12月标准草案发布后,在全球范围内共征集3000条意见。2016年6月,PC 283在多伦多召开国际会议,对这些意见进行讨论并投票,但DIS 1并未得到>75%的支持票,因此会议决定,将拟定国际标准草案第二稿(DIS 2)。之后的第一次工作组会议(WG1)将于2017年2月6日至10日在维也纳举行,会议将继续讨论已收集到的相关意见并为DIS 2的制定做准备。因此,DIS 2预计于2017年3月或4月份完成,而标准的最终草案(FDIS)最早也要于2017年10月或11月发布。

      自2013年10月起,职业健康和安全管理体系项目委员会(ISO/PC283)便开始对ISO 45001这项国际标准进行制定,此项标准包括了对职业健康安全管理体系的要求及其使用指南。ISO 45001将像ISO 9001和ISO 14001一样遵循新的高级结构要求。德国方面,NA 175-00-02 AA“职业健康和安全管理系统”的制定工作将由DIN-组织过程标准化委员会(NAOrg)全程参与,并将此标准作为(德国)国家标准(DIN ISO)发布。

公众意见:冷压成型的钢结构

澳大利亚标准协会将针对冷压成型的钢结构AS/NZS 4600发布一个公众意见草案。

 草案的主要变化如下:

.第七节的“设计的直接强度法(DSM)”包括有洞部分、非弹性储备能力、剪切和联合行动和更大范围的预审合格部分。

.第八节“测试”已经根据国家建筑规范进行更新。

.新的第九节“火”包括在温度升高的条件下消防保护设施的设计要求。

.新附录B的“结构分析方法”包括一级、二级和高级的结构分析。

.附录D“压曲应力”包括对于局部模式、畸变模式和弯扭模式的所有弹性压曲的要求。

.5.3节的“电力驱动紧固件”包括张力和剪切时对于PAFs的要求。

.修改第五节“连接”包括块剪切断裂和净截面张力以及在剪切和张力条件下的螺钉连接新要求。

此外,AS/NZS 4600草案包含了北美规范NAS S100 2012的最新的研究和澳大利亚与新西兰关于直接强度法、火和结构分析的研究。

公众评论开始于2016年12月16日,结束于2017年3月3日。

草案中的所有标准将听取公众的意见。

结束。

 

解决自平衡滑板安全的标准发布

今日,澳大利亚-新西兰自平衡滑板标准正式发布:AS / NZS 60335.2.201-2016,即家用和类似用途电器的安全-2.201部分:电动自平衡个人运输装置的特殊要求。

近年来,电池供电的电动自平衡个人运输装置(也称为滑板)在全世界普及。

AS / NZS 60335.2.201-2016安全标准为供应商、制造商和监管机构提供了明确的标准,确保了澳大利亚市场上销售的产品的安全性能。

维多利亚能源安全局局长保罗.费伦说,自去年年底自平衡滑板出现安全事故后,这一标准的迅速颁布让人感到欣慰。

费伦先生表示,新技术的快速发展和发布给世界各地的监管机构带来了诸多挑战,但是这一新标准的发布为及时做出调整设立了标杆。

“澳大利亚和新西兰的监管机构采用联合标准制定程序,与行业和社区携手合作,引领全球应对这项新技术带来的安全问题。”

 “这一标准的发布受到了热议,被看作是国际合作制定标准的成功标志,这证明了标准的制定能够跟上技术飞速发展的脚步。”

澳大利亚标准协会会长布朗温.埃文斯先生补充说道,“充分地利用标准对于保证产品和服务安全性方面起着至关重要的作用。”

 

Hoverboard standard published to address safety issues

Today, a new Australian and New Zealand standard for hoverboards was published: AS/NZS 60335.2.201-2016, Household and similar electrical appliances – Safety – Part 2.201: Particular requirements for battery powered self-balancing personal transport devices.

In recent years battery powered self-balancing personal transport devices, otherwise known as hoverboards, have grown in popularity across the world.

AS/NZS 60335.2.201-2016 provides clarity to suppliers, manufacturers and regulators to help ensure the safety of products sold on the Australian market.

Director of Energy Safety for Energy Safe Victoria, Paul Fearon, said he was pleased at the prompt development of this standard following the emergence of safety issues late last year.

“The rapid development and release of new technologies presents challenges for regulators around the world, but the publication of this new standard sets a benchmark for a timely, coordinated response.

“Through the joint Australian and New Zealand standards process, Australian and New Zealand regulators have worked together with industry and the community to lead the world in responding to the safety issues presented by this new technology.

“The successful publication of this standard, which is now being discussed and earmarked for adoption at an international level, proves that the standards process can keep pace with the rapid advances in technology,” said MrFearon.

Standards Australia CEO Dr Bronwyn Evans added that “the good use of standards plays a key role when it comes to the safety of products and services.”

优化全球动物福祉管理的ISO新规范

保护动物福祉意为着为它提供身体和精神上的需要。动物饲养不再只被看做一种食物生产的方式,还是一种伦理关怀。

顾客对于动物如何被饲养的关心日益渐增。饲养动物的健康、安乐也与食物的质量、甚至安全有紧密的联系。随着顾客对动物福祉问题的意识逐渐加深,对符合动物福祉标准的产品需求也在上升,坚持这些高标准的生产商因此拥有了竞争优势。

同样地,食品工厂也正在采取行动,以便更好地落实动物福祉管理。

国际标准化组织(ISO)新的技术规范ISO/TS 34700:2016 动物福祉管理——食物供应链中组织的一般需求与指导会帮助食品与饲料工厂制定符合世界动物卫生组织(OIE)陆生动物健康法典(TAHC)原则的动物福祉计划,确保整个供应链的农场动物福祉。

ISO与OIE曾于2011年签订了合作协议并顺其行之,ISO/TS 34700便代表了它们共同努力的结果。新的技术规范旨在支持落实相关实践,确保各个畜牧生产系统中的动物福祉。这将是经营者向外展示动物福祉管理决心的一种方式。

制定ISO/TC 34/WG  16文件的会议工作组主席弗朗索瓦.盖里博士说:“动物生产食物链的经营者将是ISO/TS 34700的第一受益人,包括牧民、牲畜运输公司及屠宰场。通过创建一个共同的动物福祉管理词汇和方法, ISO技术规范将改善食品供应链内的供应者与顾客间的必要对话,尤其是初级生产与加工人员之间的交流,这将成为一个企业对企业的工具。

ISO/TS 34700将为类似私营部门和主管机构提供一个有益的工具,来帮助他们消除规章制度中的矛盾,尤其是正为动物福祉政策推进公私合作关系的发展国家。

在ISO/TS 34700的制定中十分注重小公司的需求,这些小公司(家庭农场、小型运输公司、小型屠宰场等等)构成了大多数参与动物食品供应链的企业经营者。但对于涉及动物产品贸易的公司来说,此文件还具有国际参考价值。

其他组织——比如零售商、顾客及对保护动物福祉有兴趣的非政府组织将成为ISO/TS 34700的间接受益者,因为经营者们开始表现出对动物健康和福祉的欣赏与关心。

OIE理事长莫尼克.艾略特说道:“此项ISO技术规范将提供一个关键框架,支持OIE的动物福祉国际标准在全球范围的落实。持续对动物实施仁爱的、道德的饲养环境能够为牧民和生产者带来保障、为消费者带来信心。”

SSAFE的目标是通过公私合作关系来促进国际公认食品保护系统和标准的持续改善与全球认可,其成员也对此技术规范的制定提供了支持。

SSAFE主席西奥多拉.莫丽列.海因兹说道:“SSAFE支持动物福祉规范ISO/TS 34700的原因在于它提供了一个实际的工具,从而在遵循OIE原则的基础上提升食用动物的优良动物福祉实践,并且鼓励整条食品供应链中的所有利益相关人遵守与动物食品相关的OIE动物福祉标准。”

负责制定此技术规范的工作组召集了全球各个领域中的130多个专家。由于发展中国家和广泛利益相关人(私有企业、主管当局、非政府组织等等)的积极参与,工作组为寻求共识提供了一个具有代表性的平衡点。

与所有ISO技术规范相同,ISO/TS 34700将在三年内进行正规的系统评价,并整理反馈。

ISO/TS 34700:2016 将由ISO工作组ISO/TC 34/WG 16制定。此工作组的秘书处从属于AFNOR——法国的ISO成员。此文件可从您国家的ISO成员ISO商店内购买。

动物拥有的五大自由权:

OIE的动物福祉指导原则还在OIE TAHC的第7.1章中提到了公认的“五大自由权”,描述了人类控制下的五方面动物福祉。按目前表达的内容,动物福祉的五大自由权为:

o    免于饥饿、营养不良与饥渴的自由权

o    免于恐惧与痛苦的自由权

o    免于身体不适与热不适的自由权

o    免于疼痛、受伤与疾病的自由权

o    表达正常的行为模式的自由权

 

New ISO specification for better management of animal welfare worldwide

Protecting an animal’s welfare means providing for its physical and mental needs. The farming of animals is no longer just seen as a means of food production but as an ethical concern.

Consumers are increasingly concerned about the treatment of animals and the well-being of farmed animals is strongly associated with the quality, and even the safety, of food. As consumer awareness of animal welfare issues continues to rise, the demand for products complying with animal welfare standards is growing, giving producers who maintain these high standards a competitive advantage.

Likewise, the food industry is taking more action to better implement animal welfare management. The new ISO technical specification ISO/TS 34700:2016Animal welfare management – General requirements and guidance for organizations in the food supply chain, will help the food and feed industry to develop an animal welfare plan that is aligned with the principles of the World Organization of Animal Health (OIE) Terrestrial Animal Health Code (TAHC)* and ensure the welfare of farm animals across the supply chain.

ISO/TS 34700 represents the culmination of a joint effort between ISO and the OIE following the cooperation agreement signed in 2011 between the two organizations. The new technical specification is intended to support the implementation of relevant practices to ensure animal welfare in livestock production systems. It will be a way for business operators in the food supply chain to demonstrate their commitment to animal welfare management.

“The first beneficiaries of ISO/TS 34700 will be the business operators of the animal production food chain, including animal farmers, livestock transport companies and slaughterhouses,” says Dr François Gary, Convenor of working group ISO/TC 34/WG 16 that developed the document. “By creating a common vocabulary and a common approach to animal welfare management, this ISO technical specification will improve the needed dialogue between suppliers and customers within the food supply chain, especially between primary production and processing operators. This will be a business-to-business tool.”

ISO/TS 34700 will serve as a helpful tool for the private sector and competent authorities alike to clear up discrepancies in the regulatory framework, especially in developing countries facilitating public-private partnerships for animal welfare policy.

During the development of ISO/TS 34700, special attention was paid to the needs of small companies that make up most of the business operators involved in the animal food supply chain (family farms, small transport companies, small slaughterhouses…). But the document will also act as an international reference for companies involved in the trade of animal products.

Other parties, such as retailers, consumers and NGOs with an interest in animal welfare protection, will be indirect beneficiaries of ISO/TS 34700 as business operators begin to demonstrate their appreciation and commitment for animal health and welfare.

“The ISO technical specification will provide an important framework supporting the implementation of the OIE’s international standards for animal welfare around the world,” says Dr Monique Eloit, Director General of the OIE. “Consistent implementation of humane and ethical rearing conditions for animals provides certainty for farmers and producers, and confidence for consumers.”

The members of SSAFE, a non-profit membership-driven organization that aims to foster continuous improvement and global acceptance of internationally recognized food protection systems and standards through public-private partnerships, supported the development of the technical specification.

“SSAFE supports ISO/TS 34700 for animal welfare as it provides a practical tool for promoting good animal welfare practices for food-producing animals based on OIE principles, and encourages all stakeholders across the food supply chain to observe the OIE animal welfare standards in relation to trade in foods of animal origin,” says Theodora Morille-Hinds, President of SSAFE.

The working group in charge of developing the technical specification brings together more than 130 experts from all regions of the world, with strong participation from developing countries and a broad range of stakeholders (private sectors, competent authorities, NGOs…), providing a representative balance in the search for consensus.

As with all ISO technical specifications, ISO/TS 34700 will undergo its normal systematic review in three years’ time and feedback will need to be organized.

ISO/TS 34700:2016 was developed by ISO working group ISO/TC 34/WG 16, whose secretariat is held by AFNOR, the ISO member for France. It can be purchased from your national ISO member or though the ISO Store.

Five freedoms for animals

The OIE’s guiding principles on animal welfare also mention the universally recognized “Five Freedoms”, stated in Chapter 7.1 of the OIE TAHC, which outline five aspects of animal welfare under human control. The five freedoms for animal welfare, as currently expressed, are:

o    Freedom from hunger, malnutrition and thirst

o    Freedom from fear and distress

o    Freedom from physical and thermal discomfort

o    Freedom from pain, injury and disease

o    Freedom to express normal patterns of behavior

推动国际木材贸易发展的ISO标准

      如果没有木材我们会怎样呢?仅2015年一年,人类就消耗了多达3.1亿立方米的软木以及1.3亿立方米的硬木,总价值为1,290亿美元。随着高达18层的木结构大楼的涌现,人们对木材的需求与日俱增。由于木材种类繁多,加上每个国家出产的木材种类有限, 全球木材贸易就变得十分必要,且规模巨大。但是木材种类和国家进口政策的不同使跨境贸易面临一些挑战。制定一系列ISO标准的目就是帮助解决这一问题。

 

     由于性质多样,且在可持续管理的情况下比较环保,木材和锯材是良好的建筑材料。但是通用分类系统的缺少令国际木材贸易面临困难。因此,ISO木材结构技术委员会(ISO / TC 165)综合了60多个国家的木材生产和消费地区的专家意见,制定了一套国际标准。这套标准规定了标准框架和工作方式,确保人人适用,有利于减少贸易阻碍。

一、为什么要有国际木材分类系统?

 

     ISO木材结构技术委员会(ISO / TC 165)主席Erol Karacabeyli说:“我们行业面临的挑战之一是木材种类级别繁多,没有几千个,也有几百个,每一个都有不同的工程性能。因此,为一个建筑项目选择最适合的材料并不简单。”

 “为了解决这个日益严重的问题,欧洲曾推出一种木材分类系统,该系统要求所有的木材种类级别组合归为近十大类。然而北美的木材行业并不接受欧洲的分类系统。经过多年的工作和磋商,委员会有能力制定一套可以被所有人接受的国际木材分类系统框架。”

二、标准是什么?

 
ISO / TC 165制定的标准旨在解决木材外观和机械性能两方面的分级和测试,并为软木和硬木木材强度国际分级系统提供框架。

其中包括:

.         ISO 9709,结构木料-外观强度分级-基本原则

.         ISO 12122-1,木材结构-特征值测定-第一部分:基本要求

.         ISO 12122-2,木材结构-特征值测定-第二部分:锯材

.         ISO 13912,结构木料-机械强度分级-基本原则

.         ISO 13910,木材结构-强度分级木材-结构性能的试验方法

.         ISO 16598,木材结构-锯材的结构分类

.         ISO 18100,木材结构-指接木材-加工及生产要求*

*正在制定中

三、国际范围的采用

      当所有国家都在采用ISO标准时,这些标准的真正益处才能显现。可以预料的是,适用于锯材结构分类的ISO 16598在全球范围内采用会促进成千上万个软木和硬木品种的贸易。

四、展望未来

ISO / TC 165还有一些项目正在进行,包括国际标准和一些关于以下内容的相关文件:

.         交叉复合木材(CLT)

.         木地板震动设计方法

.         木材混凝土板的剪切连接, 这是一个为设计师提供新选择的混合系统

.         钻尾自攻螺丝框架

.         木质产品的长期结构性能

.          木结构连接的屈服点

.         竹子

 

Facilitating international trade of wood with ISO standards

Where would we be without wood? In 2015 alone, we humans consumed a whopping 310 million cubic metres of softwood lumber and 130 million cubic metres of hardwood lumber, totalling USD 129 billion. And the hunger for wood is increasing, with wooden buildings as high as 18 storeys starting to pop up. With the diversity of types of wood and the fact that not every country produces every type of wood, the global trade of timber is a huge and necessary business. But not all wood – nor import policy – is alike, making cross-border trade somewhat of a challenge. A range of ISO standards aim to help.

 

Lumber, or sawn timber, is often the material of choice for construction because of its diversity of properties, and, if sustainably managed, is environmentally friendly. But international trade of lumber has its difficulties due to a lack of classification systems that are universal to all. And so the ISO technical committee on timber structures (ISO/TC 165), drawing on the input of experts from over 60 countries, for the most part in timber-producing and -consuming regions, developed a suite of International Standards that help reduce these barriers to trade by producing standardized frameworks and ways of working that can be used by everyone.

Why have an international lumber classification system?

“One of the challenges within the industry is that there are hundreds, if not thousands, of timber species-grade designations, each with unique engineering properties, so choosing the most appropriate for a construction project is not easy,” said Erol Karacabeyli, Chair of ISO/TC 165.

“To address this ever increasing problem, Europe introduced a lumber classification system that required all lumber species-grade combinations to be categorized into about ten classes. The European system, however, was not acceptable to the North American industry. But after years of work and negotiations, the committee was able to develop the framework for an international lumber classification system that is acceptable to all.”

What standards?

The standards developed by ISO/TC 165 are designed, therefore, to address grading and testing of both visually and mechanically graded lumber and provide a framework for an international strength classification system for both softwood and hardwood lumber. These include:

.         ISO 9709, Structural timber – Visual strength grading – Basic principles

.         ISO 12122-1, Timber structures – Determination of characteristic values – Part 1: Basic requirements

.         ISO 12122-2, Timber structures – Determination of characteristic values – Part 2: Sawn timber

.         ISO 13912, Structural timber – Machine strength grading – Basic principles

.         ISO 13910, Timber structures – Strength graded timber – Test methods for structural properties

.         ISO 16598, Timber structures – Structural classification for sawn timber

.         ISO 18100, Timber structures – Finger-jointed timber – Manufacturing and production requirements*

*Under development

Towards international adoption

The real benefit of the standards will be realized when all countries adopt them nationally, and it is anticipated that ISO 16598 for the structural classification of sawn timber will eventually be adopted globally, facilitating the trade of thousands of types of softwood and hardwood lumber.

Looking forward

ISO/TC 165 also has a number of projects in the pipeline, including International Standards and related documents for:

.         Cross-laminated timber (CLT)

.         Vibration design method for timber floors

.         Shear connections for timber-concrete slabs, a hybrid system that gives designers new choice

.         A framework for self-drilling screws

.         Long-term structural performance of wood-based products

.         Yield point for connections in timber structures  

.         Bamboo

BSI对欧洲混凝土建筑标准进行了修订

BSI日前对BS EN 206 混凝土产品的规格、性能、生产和一致性标准进行了修订。此项标准适用于工地水泥浇筑、预铸框架以及建筑和市政工程的预铸框架产品。

       这项标准涵盖了所有类型的混凝土和几乎全部预铸混凝土种类。BS EN 206同时还包含用于道路铺面的混凝土,关于道路铺面混凝土,该标准引用欧洲混凝土路面标准对其进行另外的增补要求。

       修订后的标准强调混凝土的使用寿命要求达到甚至超过100年,这样才能保证在公平的基础上对其与其他建筑材料的耐久性进行比较。

 

BS EN 206包括:

l  混凝土的成分

l  新拌和硬化混凝土的特质以及它们的鉴定

l  混凝土成分的限制

l  混凝土的规格

l  新拌混凝土的运输

l  生产控制步骤

l  产品一致性的标准和评估

 

这项标准对于提供或需要关于预拌混凝土信息的建筑项目内涉及的所有人员都大有用处,包括工程承包商、专家、生产商、技术顾问和建筑工程师。

       BS EN 206的制定是在各方合作达成共识的基础上再结合专家意见。这些专家都是来自建筑产品行业,例如英国现拌混凝土协会、建筑工程师、建筑产品生产商、技术顾问和行业协会代表。

       BSI的建筑环境部门负责人安东尼.伯德说道,对于混凝土特性的需求取决于其最终用途。其中就包括防止外露混凝土离析的强度和最大骨料粒径。这些差异为技术顾问和生产商提供指南,让他们以BS EN 206进行选择。修订后的标准更为清晰明了,让选择过程也更为简单。

       BS EN 206的修订是BSI参与CEN/TC 104的结果。BS EN 206不包括混凝土生产和运输过程中保护工人的健康和安全要求。

 

European Standard for concrete structures is revised

BSI, the business standards company, has revised BS EN 206 Concrete – Specification, performance, production and conformity. The European Standard applies to concrete for structures cast in situ, precast structures, and structural precast products for buildings and civil engineering structures.

The standard covers all types of concrete and nearly all types of precast concrete*. BS 206 also covers concrete for pavements where there are additional complementary requirements cited in the European Standard for Concrete pavements.

The revision specifically addresses that concrete may be designed for a working life of up to and over 100 years. This ensures that when its sustainability credentials are compared to other building materials the comparison may be carried out on an equitable basis. 
 

BS EN 206 covers:

.         Constituents of concrete

.         Properties of fresh and hardened concrete and their verification

.         Limitations for concrete composition

.         Specification of concrete

.         Delivery of fresh concrete

.         Production control procedures

.         Conformity criteria and evaluation of conformity

The standard will be of use to all members of a construction project who provide or require information on ready mix concrete, including construction contractors, specialists, manufacturers, specifiers and structural engineers.

BS EN 206 was developed using a collaborative consensus-based process with input from experts within the construction product sector such as the British Ready Mix Concrete Association, as well as structural engineers, construction product manufacturers, specifiers and trade association representatives.

Anthony Burd, Head of Built Environment at BSI, said: “The characteristics of concrete that may be needed depends on its end use application. These can range from such things as strength, maximum aggregate size or consistency to visual concretes where is on display. With such an array of variations possible it is useful to have guidelines for the specifier and the producer to refer to. BS EN 206 can help with this, and now with the added clarity this amendment brings, this process is much easier.”

The amendment to BS 206 was a result of BSI’s participation in the CEN technical committee CEN/TC 104. BS EN 206 does not cover health and safety requirements for the protection of workers during production and delivery of concrete.

 

 

BSI发布了新临床服务标准

英国标准协会(BSI)联合临床服务认证联盟(CSAA)共同发布PAS 1616医疗保健-临床服务供应-规范,旨在为帮助临床服务供应商提供物有所值的高效服务,

PAS 1616 包含从预防保健到各方面护理的所有服务,以及临床用户和护理人员接触的全过程,从第一次接触基层医护人员到最后出院,包括家庭护理在内。PAS 1616还面向有复杂需求的临床用户以及临床服务,帮助临床服务在适当时机推陈出新。

随着临床服务用户需求的增加,加上资源方面的限制,医疗保健供应面临的挑战越来越大。同时,向监管者、委员、资助者和系统设计者等利益相关方展示其服务符合要求以及持续在实施改进的需求也不断加大。医疗保健拥有一系列配套设施,包括从学校体检和接种疫苗的公共卫生,到专科临床服务和家庭服务的临终关怀。

PAS 1616 有助于形成临床路径的不同临床服务和医疗服务机构间的合作和沟通,为各机构提供一致的结构设置、专业术语和交流方式。PAS 1616 能够让工作人员和领导团队分配各方权利,并在明确的职权范围内提供临床服务。

 

PAS 1616的优点

l  遵守PAS 1616能够让临床服务用户明确他们能得到的临床服务;

l  无论临床服务有没有外部评价机制,PAS 1616能使其不断自评和提升;

l  可以使临床服务和体系的制定遵守PAS标准的相关要求;

l  帮助临床服务保持纪录和文件的持久性,有助于监管机构的减负和效率提升。BSI市场开发管理与恢复部门总监安妮.海耶斯说:“PAS 1616 为总裁、经理和临床服务带头人提供一个适用于临床服务的框架,是提高标准和质量这一长期目标中的第一步。PAS 1616的目标是通过提供结构和指导,填补临床服务中市场开发管理和恢复方面的战略组织缺陷,从而节省时间,减少资源浪费。任何临床服务方都能审视目前的服务状况,然后创建一个合适的提升路线图。”

PAS 1616包含了临床服务的计划和定义;领导力、战略和管理方法;以人为本的治疗和/或护理;风险和安全;临床评价;有各种需求的临床服务用户;如何为临床服务配备人员;提升、创新和改变;以及如何培训未来的员工。PAS 1616涵盖医院环境中的临床服务,但不是专门用于此类临床服务。它不包括有特定服务需求的个别临床服务。

PAS 1616是以下机构中的各个专家通力合作,达成共识后的结果:英国特需理疗师协会、BSI消费者和公众利益网络、医疗领导和管理学院、健康与社会保健认证论坛(HaSCAF)、英格兰国民保健署、NHS临床调试组、英国国家卫生与临床优化研究所、RCP病人和护理人员网络成员、英国卫生部监察员、英国健康与社会保障专业标准局、英国皇家全科医师学会、英国皇家护理学院、英国皇家内科医学院(RCP)、英国皇家医师学院认证单位、英国皇家外科医学院和西米德兰兹质量审核服务。

PAS 1616是一系列资源中的一部分,由医疗质量改进伙伴关系(HQIP)代表CSAA发布。2016年11月25日会召开PAS 1616发布会,会议的主要领导人来自中国质量认证中心(CQC)、英国国民医疗服务改进体系(NHS Improvement)、HQIP、英国皇家学院和其他认证团体。

 

New clinical services standard published

BSI, the business standards company, has published PAS 1616, Healthcare – Provision of clinical services – Specification, in association with the Clinical Services Accreditation Alliance (CSAA) to help clinical services providers deliver efficient services which are good value for money.

PAS 1616 covers the full range of services from preventative care through all aspects of care that clinical service users and their carer(s) encounter on their journey, from first contact with a primary care health professional through to their exit from the clinical service, including home care. It includes requirements for clinical users with complex needs and for clinical services to seek and adopt innovation when that is considered appropriate.

Healthcare provision is becoming increasingly challenging, with clinical service users presenting more complex needs under constrained resources. There is also a growing need to demonstrate to stakeholders such as regulators, commissioners, funders and system planners that requirements are being met and improvements implemented. Healthcare is provided in a wide range of facilities and settings, from public health, which includes screening and vaccinations in schools, to end-of-life care in specialist clinical services and in the home.

PAS 1616 can facilitate collaboration and communication across the different clinical services and healthcare providers that make up a clinical pathway, providing them with consistency of structure, terminology and communications. This can allow clinical services, staff members and leadership team ownership over the clinical service and empowerment to act within a clearly given remit.

Benefits of PAS 1616:

.         Compliance with PAS 1616 can provide clarity to clinical service users about what they can expect from the clinical service

.         Can enable a clinical service to continually self-assess and improve, regardless of whether there is any existing external evaluation scheme within that clinical service

.         Can enable service and systems planners and funders to commission on the basis of adherence to the requirements of the PAS

.         Has the potential to reduce the burden and increase the effectiveness of regulation by helping clinical services to maintain robust records and documentation which could be used to show compliance with regulations

Anne Hayes, Head of Market Development for Governance and Resilience at BSI, said: “PAS 1616 provides CEOs, managers, and clinical leaders with a framework to follow for their clinical service; a first step in the long-term aim of raising standards and improving quality. It aims to fill a strategic and Market Development for Governance and Resilience organizational gap by providing a structure and guidance for clinical services, thereby saving time and reducing wasted resources. Any clinical service can now review its current level of provision and create a roadmap for improvement.”

PAS 1616 covers clinical service planning and clinical service definition; leadership, strategy and management; person-centred treatment and/or care; risk and safety; clinical effectiveness; clinical service users with complex needs; staffing a clinical service; improvement, innovation, and transformation; and educating the future workforce. It covers clinical services within hospital settings, but it not exclusively for such clinical services. It does not cover service-specific requirements for an individual clinical service.

PAS 1616 was developed using a collaborative, consensus-based approach using experts from such organizations as: the Chartered Society of Physiotherapy, BSI Consumer & Public Interest Network, the Faculty of Medical Leadership and Management, the Health and Social Care Accreditation Forum (HaSCAF), NHS England, NHS Clinical Commissioning Group, National Institute for Health and Care Excellence, the Member of RCP Patient and Carer Network, Monitor – the Department of Health, the Professional Standards Authority for Health and Social Care, the Royal College of General Practitioners, the Royal College of Nursing, the Royal College of Physicians, the Royal College of Physicians Accreditation Unit, the Royal College of Surgeons and West Midlands Quality Review Service.

PAS 1616 is part of a suite of resources being delivered by the Healthcare Quality Improvement Partnership (HQIP) on behalf of the CSAA.  A launch event will take place on 25th November 2016, featuring leaders from CQC, NHS Improvement, HQIP, Royal Colleges, and the wider accreditation community.

 

印刷业能源管理标准化(EMSPI)

       印刷业能源管理标准化(EMSPI)旨在进一步提高欧洲印刷业中小企业能源利用效率。其主要目标是通过实施建立在欧洲标准EN 16001和/或全球标准ISO 50001上的能源管理系统(Energy Management System),以获得最大程度的节能。

具体目标是:

1)根据欧洲标准EN 16001和/或全球标准ISO 50001,制定适用于印刷业中小企业的具体能源管理措施,落实印刷业能源高效使用;

2)制定具体部门的实施指南,包括充分利用和开发现有的方法与工具(绿色营销计划,碳足迹计算),以便在中长期内,在战略和竞争力框架中实现系统和连续的能源消耗节约;

3)通过利用之前制定的指导方针,在100家中小企业实施能源管理标准(长期项目);

4)确定在欧洲各地的印刷业节能服务公司(ESCO)面临的障碍和机遇;

5)在欧洲各国,提高能源效率工具对所有印刷行业的利益相关者有益的意识;

6)培训中小型企业人员作为能源管理者,以在节能和节约成本的标准执行后维持节能和管理程序;

7)增强中小企业管理者的能力和技巧,在产业层面达到“临界质量”或乘数效应,扩大已开发的工具和特定通信材料。

达到预期结果的关键步骤:

1)根据环境保护工程师协会(IEE)之前的计划,更新印刷业能源诊断;

2)对适应特定标准的结果加以分析;

3)开发项目材料;

4)汇集并甄选中小企业;

5)实施适合的能源管理系统;

6)评价与传播。

成果:

l  100家中小企业能源效率提升。

l  100家中小企业根据EN 16001和/或ISO 50001实行能源管理系统

l  项目实施期间,每100家中小企业实现年能源节约40000GJ

l  项目实施期间,每100家中小企业实现年二氧化碳排放减少880吨

l  项目实施期间,每100家中小企业实现年能源成本减少915000欧元

 

Energy Management Standardization in Printing Industry (EMSPI)

EMSPI aims to promote actions for increase the energy efficiency at European small and medium sized enterprises (SMEs) of the Printing Industry.The main objective is to reap the maximum energy savings by promoting the implementation of Energy Management System based on the European standard EN 16001 and/or the global standard ISO 50001. The specific objectives are: 1) To develop a specific adaptation of European standard EN 16001 and/or the global standard ISO 50001 for the energy management in printing SMEs, facilitating the implementation of energy efficiency measures in printing industry. 2) To develop sector-specific implementation guidelines including the exploitation of existing approaches and tools (Green Marketing Plan, Sector Carbon Footprint Calculation), in order to create systematic and continuous energy consumption savings in the medium and long term within a strategic and competitiveness oriented framework; 3) To implement the specific energy management standard at 100 SMEs (during lifetime project) by using the previously developed guidelines. 4) To identify barriers and opportunities for ESCOs in the Printing Industry across Europe; 5) To enhance the awareness on the benefits of energy efficiency tools to all the Printing Industry stakeholders in European countries; 6) To train SMEs personnel as Energy Managers to maintain energy savings and management procedures after standard implementation aiming to save energy and costs; 7) To strengthen the capabilities and skills of SMEs managers to achieve a "critical mass" or multiplier effect at industry level in order to expand the developed set of tools and specific communication materials. Key steps to achieve the expected outcomes:1) Update energy diagnosis of Printing Industry based in previous IEE projects;2) Analysis of results to develop an adapted specific Standard;3) Development of project materials;4) Collection and selection of SMEs;5) Implementation of adapted Energy Management System;6) Evaluation & Dissemination.

Results

  • Specific baseline audit energy management and potentials on energy efficiency improvement of 100 SME’s
  • 100 SME’s with a fulfilled energy management system according to EN 16001 and/or ISO 50001
  • 40.000 GJ of yearly potential energy savings per 100 SMEs during the project lifetime
  • 880 ton CO2 potential emission reduction each year per 100 SMEs during the project lifetime
  • 915.000 € of potential decreasing yearly energy costs per 100 SMEs during the project lifetime

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