PPE Legal Series

PPE standards as per EU /US Canadian health and safety law/import laws : Quick Reference Guide

This is a quick Reference Guide for the EU Standards for Personal Protective Clothing including Fire Fighting ApparEl and other health and SAFETY Apparel *We will edit this list periodically with further information.    CLOTHING FOR PROTECTION AGAINST HEAT AND FLAMES EN 1486 :2007 EN ISO 11612 :2008   FIRE Fighting AppareL EN 469 :2006

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PPE Legal Series

Exporting PPE to Saudi Arab?

The Saudi Food and Drug Administration has a very clear legal regime, even though certain matters may get your PPE consignments stuck at customs.For this purpose we often recommend documenting these matters in your commercial PPE contracts with Saudi buyers and end buyers. SFDA did make some commendable Regulatory efforts post COVID and expedited the

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PPE Legal Series

Understanding CE Marks and the Laws relating to Notified Bodies

The PPE crisis in the Post COVID era has made the provision of rigorous regulatory and quality management reviews and product certifications for medical device manufacturers — around the world a very important field of review for lawyers. The modern healthcare lawyer or for that matter any lawyer working on an international PPE contract must

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PPE Legal Series

BSI CE Notified Body Number changes and how it affects procurement and certification for PPE manufactured in 2020

For those of you, buying or sourcing PPE (especially the 3M 9300 series masks) in Europe, a very subtle change has occurred in the CE (Notified Body) numbers of the FFP1, FFP2 and FFP3 Masks and other PPE, if the CE certificate of that product was coming from BSI The British Standards Institute).A copy of

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PPE Legal Series

International Legal Standards for Medical Gloves FDA Guidance and D6319 – 10(2015) ASTM International (ASTM)

Additional Notes from D6319 – 10(2015) ASTM International (ASTM) Title: Standard Specification for Nitrile Examination Gloves for Medical Application Description This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures. Standard Type(s) Specification An explicit set of requirements to be satisfied by a material, product, system, or service:

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PPE Legal Series

Importing medical masks and respirators into the United Kingdom : Legal Regulations governing Type IIR Medical Masks

Surgical Face masks – Type IIR Applicable UK /EU law : Standards/Directives/Legislative requirements STANDARD / CERTIFICATION Surgical facemasks must conform to: BS EN 14683:2019 or any equivalent standard Medical face masks.    Types : Surgical Type IIR face mask with loops/ties, no visor, no anti-fog strip  Surgical Type IIR face mask with loops/ties with no

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