The German Institute for Standardization (DIN), in agreement with the European Commission, has decided to make freely available a series of European standards (ENs) for medical devices and personal protective equipment, in a move to support the fight against the COVID-19 pandemic.

The aim is to tackle the severe shortage of protective masks, gloves and other products in European countries. Providing free access to the standards will facilitate the work of the companies wishing to reconvert their production lines in order to manufacture the equipment that is so urgently needed. The standards are aimed purely at professional users.

Rüdiger Marquardt, Member of DIN’s Executive Board, adds: “Standards are of utmost importance in ensuring the safety of medical devices and personal protective equipment and providing support and guidance to the manufacturers who produce them. Together with other national standardizations, CEN and CENELEC, DIN is committed to supporting the efforts of the European Commission in the fight against coronavirus.”

The current editions of the standards are available free of charge until further notice. These standards describe the key requirements to be met by filter masks, medical gloves and protective clothing. The free standards may include:

Protective masks

DIN EN 149:2009-08: Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking
DIN EN 14683:2019-10: Medical face masks – Requirements and test methods

Eye protection

DIN EN 166:2002-04: Personal eye-protection – Specifications

Protective clothing

DIN EN 14126:2004-01: Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
DIN EN 14605:2009-08: Protective clothing against liquid chemicals – performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])
DIN EN ISO 13688:2013-12 Protective clothing – General requirements (ISO 13688:2013)
DIN EN 13795-1:2019-06: Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
DIN EN 13795-2:2019-06: Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits

Gloves

DIN EN 455-1:2001-01 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes
DIN EN 455-2:2015-07: Medical gloves for single use – Part 2: Requirements and testing for physical properties
DIN EN 455-3:2015-07: Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
DIN EN 455-4:2009-10: Medical gloves for single use – Part 4: Requirements and testing for shelf life determination
DIN EN 420:2010-03: Protective gloves – General requirements and test methods
DIN EN ISO 374-1:2018-10 Protective gloves against dangerous chemicals and micro-organisms – Part 1: Terminology and performance requirements for chemical risks
DIN EN ISO 374-5:2017-03: Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)

Medical devices

DIN EN ISO 10993-1:2010-04: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Safety and resilience

DIN EN ISO 22301:2019-10: Security and resilience – Business continuity management systems – Requirements (ISO/DIS 22301:2019)
ISO 22395: 2018-10: Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
ISO 22320: 2018-11: Security and resilience – Emergency management – Guidelines for incident management
ISO 22316 2017-03: Security and resilience – Organizational resilience – Principles and attributes

Risk management

ISO 31000: 2018-02: Risk management – Guidelines

The button with link to these free standards is provided by DQS Academy at the end of this webpage: https://www.dqs.hk/training/schedule/.

About DIN

DIN (Deutsches Institut für Normung e.V. in German) is one of the primary shareholders of DQS. Founded in 1917, the German Institute for  Standardization (DIN) with a history over 100 years, is the German national organization for standardization and is the German ISO member body. DIN is the standards developer representing Germany at the international and European levels. DIN standard designation shows DIN # and varies to DIN EN #, DIN ISO #, DIN EN ISO #.

 

免費的醫療器械和個人防護設備 歐盟標準

德國標準化學會 (DIN) 與歐盟委員會達成共識,決定免費提供一系列用於醫療設備和個人防護設備的歐盟標準 (EN),以支持相關行業對抗COVID-19新冠肺炎疫情的努力。

其目的是解決許多歐洲國家當前面臨的防護口罩、手套和其他防護產品的嚴重短缺問題。免費標準的提供將方便許多希望轉換其生產線以製造急需的產品的公司的工作。這些標準僅針對專業用戶。

DIN執行委員會成員Rüdiger Marquardt說:“標準對於確保醫療器械和個人防護設備的安全以及為生產它們的製造商提供支持和指導至關重要。 DIN與其他標準組織CEN和CENELEC一起,致力於支持歐洲委員會在抗冠狀病毒方面的努力。”

當前版本的標準免費提供,直至另行通知。這些標準描述了過濾口罩、醫用手套和防護服必須滿足的關鍵要求。 相關免費標準如上所列。

DQS 學堂 在後列網頁的末尾提供獲得這些免費標準的鏈接: https://www.dqs.hk/training/schedule/

關於 德國標準化學會 (DIN)

德國標準化學會 (DIN) 是 DQS 的主要股東之一。DIN 創建於 1917 年,至今已經超過百年歷史。DIN 是德國國家級標準化組織,也是 ISO 中代表德國會籍的會員機構。由德國標準化學會制定的標準,前面都有 DIN 字樣,同時也會制定 DIN EN#、DIN ISO#、DIN EN ISO# 等標準,在歐洲及世界各國廣泛採用。

 

Ref Source: DIN website.