The medical devices’ Regulations and the role of Standards

With the new medical devices and in-vitro diagnostic medical devices Regulations (MDR and IVDR) published on 5 May 2017 by the European Commission, the long process of revising the European regulatory framework has ended. The Regulations pose new challenges to the various stakeholders involved in the sector due to the changes that they have introduced. They have expanded the scope of products, there are more rigorous requirements for clinical evaluations as well as changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by European Notified Bodies. In addition, the IVDR introduces a new risk-rule classification system based on the Global Harmonization Task Force’s rules for classification, which considers patient impact for the first time.

The Regulations recognise the important role of standardisation in the field of medical devices. By complying with harmonised standards, manufacturers may demonstrate conformity with the general safety, performance, quality and risk management requirements of the Regulations, and thereby gain access to the European market. In addition to standardisation, the Regulations authorise the European Commission to publish common technical specifications that will represent state-of-the art and will be part of the products’ evaluation process. Several questions remain open, however, regarding the development of the common specifications and their co-existence with harmonised standards.

Given the complexity of the new regulatory framework, the scope of the changes it has introduced, and the short timeframe for the transition period, it is important to provide an open space for discussion and exchange of information and ideas regarding the new Regulations and the way forward. This is the objective of the Seminar on ‘The new regulations on medical devices and related standards: ensuring a successful transition’, which is organised by CEN and CENELEC and will take place on 21 September 2017. The focus of the seminar will be on standardization and its role in supporting the new Regulations, the future of harmonised standards under the Regulations, and the need to ensure a smooth and successful transition for the benefit of European citizens and industry.

Consult the agenda of the seminar and register before 19 September.

“How does standardization contribute to IT security in the Digital Single Market?”

This was the topic of the DIN discussion event hosted by the Permanent Representative of the Federal Republic of Germany to the European Union in Brussels on 11 July 2017. 

Presenting to over 80 participants, DIN Executive Council member Rüdiger Marquardt proffered standardization as an instrument that can be used to develop detailed solutions pursuant both to the legislative requirements of the German NIS directive and the General Data Protection Regulation. Many fundamental standards already exist in the ISO/IEC 27000 series on IT security management. Sector-specific standards must now follow, the responsibility lying with standards organizations to cooperate with one another in a manner that preserves the consistency of the transnational body of standards.

Rüdiger Marquardt presented Maximillian Strotmann, member of Commissioner Andrus Ansip’s cabinet, with the German Standardization Roadmap on IT Security, published by KITS.

Mr Strotmann welcomed the contribution of standardization to cyber security and the creation of a Digital Single Market. The Commission does not wish to politicize standardization unnecessarily, said Strotmann, acknowledging that individual Directorates General would have to cooperate more closely when assigning standardization mandates.

Sibylle Gabler, Head of Government Relations at DIN, discussed possible gaps in legislation governing network security of the Internet of Things with a highly qualified panel. Further topics discussed were the ISO standard “Common Criteria” pertaining to IT security of products, a risk-based approach and numerous future possibilities for an IT security certification.

The following panellists took part: Dr. Andreas Schwab, Member of the European Parliament and Rapporteur on the NIS directive, Luigi Rebuffi, General Secretary of the European Cyber Security Organisation, Bernd Kowalski, Head of the Federal Office for Information Security, Markus Reigl, Director of the Technical Regulation and Standardization at Siemens as well as Jean-Pierre Quémard, Chair of the Cyber Security Coordination Group.

当您将手机充电器插入墙上的插座时，怎么知道就是适合的呢？

如果您将同一充电器从澳大利亚带到新西兰，那么如何确定它在两国都可以用呢？

关于在澳大利亚和新西兰使用的插头和插座的新版标准AS / NZS 3112关于批准和测试规范-插头和插座-出口于今日发布。

AS / NZS 3112为电气行业，包括制造商、测试实验室和监管机构提供了插头和插座的要求和测试方法。

标准的主要变化包括：

•现在包括可拆卸插头部分的规格；

•需用修订和添加的图表来说明插头和插座的尺寸；

•需说明插头和插座的配置；

•更新了以下测试要求：

o入口防护（IP）

o不可拆卸的部件

o绝缘冲孔端子

电气配件技术委员会EL-004主席丹尼斯.加尔文（Mr Dennis Galvin）先生对该项标准的修订做出评价。

加尔文先生说：“AS / NZS 3112的修改将在设计和生产过程中非常有利于生产商，同时，在评估标准的遵守情况时，还会对实验室、监管机构和认证机构进行测试。

澳大利亚标准协会会长布朗维恩.埃文斯博士解释了这一标准修订发布的重要性。

埃文斯博士说：“由于缺乏插头和插座的国际标准，国家标准机构要定期审查其标准，以适应技术变革和全球化的影响。”

Safe and Reliable Plugs and Socket Outlets 

When you plug your phone charger in to a wall socket, how do you know that it will fit?

If you take that same charger from Australia with you to New Zealand, how can you be sure it will work in both countries?

A new edition of the standard for plugs and sockets used in Australia and New Zealand, AS/NZS 3112, Approval and test specification – Plugs and socket-outlets, was published today.

AS/NZS 3112 provides the electrical industry, including manufacturers, test laboratories and regulators, with requirements and test methods for plugs and socket outlets.

The major changes to the standard include:

• Specifications for detachable plug portions are now included

• Dimension requirements for plugs and sockets clarified through revised and added diagrams

• Plug and socket configurations have been clarified

• Updated testing requirements for:

o Ingress protection (IP)

o Non-detachable parts

o Insulation piercing terminals

Chair of the technical committee EL-004, Electrical Accessories, Mr Dennis Galvin commented on this revision.

“The changes to AS/NZS 3112 will significantly benefit manufacturers during design and production but also test laboratories, regulators and certifiers when assessing compliance to the standard,” said Mr Galvin.

CEO of Standards Australia, Dr Bronwyn Evans explained the importance of this publication.

“In the absence of an international standard for plugs and sockets, it is important that national standards bodies regularly review their standards to accommodate technological change and the effects of globalisation,” said Dr Evans. 

Future development of onsite battery storage standards in Australia

On 15 August 2017 Standards Australia concluded public consultation on the draft battery storage standard that has been in development for some time.

Over three thousand comments were received on the draft, with many relating to how systems should be installed in a residential context.

Given the significant response to the draft standard, along with the fact that this is a new building technology with limited existing direction from governments, Standards Australia has offered to bring key stakeholders together to start a discussion and establish a framework through which these public policy tensions can be addressed.

Mandated residential construction requirements are ultimately public policy matters for governments. Australian Standards are voluntary unless called up by governments, and are only published if consensus is reached between industry, government and community interests.

As an independent technical standards development organisation, Standards Australia is keen to see industry and government work together to find a way forward on how residential construction requirements for onsite batteries should be set.

In Standards Australia’s view, our technical committee is not the appropriate forum to resolve the public policy tensions related to public safety, clean energy and minimum residential construction requirements. If there are policy issues for the respective governments to address, this should be determined before any further standards development work is progressed.

Standards Australia will continue to work with its technical committee and all stakeholders on this issue and hopes that a parallel policy dialogue will give our technical committee the guidance it needs to get on with the technical work.

In the meantime, consideration is being given to how best to work with our technical committee on the other important requirements contained in the draft standard.

Learning from the best: a new standard for education providers

Today’s knowledge economy requires diverse training and learning services beyond the formal, national education system. A new standard aims to not only help providers improve their service, but provide recognition and credibility on the international market.

ISO 29993 Learning services outside formal education – Service requirements is designed to improve transparency and credibility in the market by providing the minimum requirements for internationally agreed levels of quality learning services.

Daniel Graf, chair of ISO/TC 232, the ISO technical committee that developed the standard, whose secretariat is held by DIN, ISO’s member for Germany, said: “Not only will learning providers benefit through improving quality and providing an internationally recognized standard that harmonizes many local, private and national standards, learners themselves benefit through having clearer information about what they can expect.

“ISO 29993 recognizes the importance of learners being able to make informed choices, by requiring the provider to give clear information about what they can expect to learn, and who the provider is.”

Take me higher – a new standard for weather balloons just published

As worldwide research into weather patterns and natural disasters rises, so too does the use of meteorological balloons. Increasing global trade and demand for balloons that provide accurate data requires an international approach. A new ISO International Standard has just been published to take them to the next level.

Meteorological – or weather – balloons are designed to measure weather conditions by carrying atmospheric measurement instruments to higher altitudes, thus playing an important role in not just forecasting the weather, but predicting natural disasters and advancing scientific research in this area.

A new International Standard, ISO 17717 Meteorological balloon – Specification has just been published, outlining the minimum requirements for their production as well as test methods to ensure quality, reliability and durability.

Mr Deng Yizhi, project leader and member of ISO/TC 45/SC 4, the technical committee that developed the standard, whose secretariat is held by DSM, ISO’s member for Malaysia said: “Organizations involved in the production and distribution of weather balloons have, up until now, had to rely on company-developed standards and various types of national technical requirements to manage product quality, making it complicated to demonstrate quality levels when dealing with the international market.

“ISO 17717 will help to harmonize current standards in the area, as well as ensure overall quality, while providing a platform to enable more advanced technology to flourish.”

First UK plant certified by BSI to automotive quality management standard

BSI (British Standards Institution) is proud to announce that Magna International’s Stadco facility in Castle Bromwich is the first UK facility to be independently assessed by BSI and achieve certification to the automotive quality management system standard, IATF 16949:2016.

The new standard, which was published in October 2016, outlines the requirements for an effective Quality Management System (QMS). Adhering to this standard is mandatory for all Original Equipment Manufacturers (OEM) and suppliers in the automotive industry globally. Organizations are required to transition to the new standard by 14 September 2018.

Robert Brown, Global Automotive Specialist at BSI said: “Magna should be very proud that they are the first plant in the UK to achieve the updated certification from BSI. Achieving this standard is critical for automotive companies to continue to do business, deliver quality products and continually improve.”

“We would encourage other BSI customers to make the transition as early as possible – BSI is ready with a fully resourced team of expertly trained auditors to help make the transition as smooth as possible.” 

IATF 16949 builds on the revised Quality Management Systems Standard ISO 9001. The new standard has been updated to include a high level structure featuring terms, definitions, headings and text common to all management system standards; this allows for easier integration when implementing multiple management systems. The new standard also encourages a risk-based approach to encourage preventative action and ensure continuous improvement.

“This achievement comes as a result of our internal management system and approach to quality,” said Chris Fisher Stadco Group Managing Director. “Our team is focused, and worked extremely hard to reach this certification. Ensuring quality in everything we do is a clear priority of our business and we are well on the way to having all of our UK sites successfully transitioned to the IATF standard.

“Exceeding customer satisfaction requirements and delivering high quality products are of the utmost importance to our world class manufacturing efforts,” said Mike Sinnaeve, Magna’s Global Vice President of Operational Improvement and Quality. “It is a great honour to be the first facility in the United Kingdom to be certified as it is a true testament to their commitment to quality and sets the benchmark.”

Tracking the Sustainability of Manufacturing Processes

ASTM International’s committee on sustainability (E60) has developed a new guide that will help companies set reasonable, realistic operational objectives for reducing the environmental impact of their own manufacturing processes.

The standard (soon to be published as E3096, Guide for the Definition, Selection, and Organization of Key Performance Indicators for Environmental Aspects of Manufacturing Processes) uses key performance indicators (KPIs) to measure how well an objective for self-improvement is being met.

“Using this guide, industrial users will develop sets of KPIs to assess the sustainability performance of their manufacturing processes,” says ASTM International member Shaw C. Feng of the U.S. National Institute of Standards and Technology in Gaithersburg, Maryland. According to Feng, the standard helps users identify what to measure to determine whether their sustainability goals are being met. Good measurements will be specific, measurable, attainable/achievable, relevant, and time-bound, among others.

Manufacturers can use the guide to help set measurement priorities for tracking and reducing environmental impacts, such as harmful substances, that can be generated by the manufacturing process.

Industry professionals are invited to participate in pilot implementations of the guide to help improve future versions based on experience.