Guidance

Technical specifications for personal protective equipment (PPE)

The documents attached define the technical and regulatory standards for PPE.

• From: Cabinet Office and Department of Health and Social Care
• Published: 30 March 2020
• Last updated: 14 February 2022 — See all updates

This publication was withdrawn on 3 March 2023

This page has been withdrawn because it’s out of date.

Documents

[Withdrawn] Transparent face mask technical specification

HTML

[Withdrawn] Specification for hand wash

PDF, 148 KB, 2 pages

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[Withdrawn] Specification for hand wash

MS Word Document, 18.5 KB

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[Withdrawn]: Specification for chlorine tablets and granules

PDF, 449 KB, 2 pages

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[Withdrawn] Specification for chlorine tablets and granules

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[Withdrawn] Specification for fit testing solutions

PDF, 294 KB, 1 page

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[Withdrawn] Specification for fit testing solutions

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[Withdrawn] Adult body bag specification

PDF, 723 KB, 1 page

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[Withdrawn] Adult body bag specification

MS Excel Spreadsheet, 170 KB

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[Withdrawn] Orange clinical waste bags specification

PDF, 718 KB, 1 page

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[Withdrawn] Orange clinical waste bags specification

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Details

These documents are for new suppliers and manufacturers when they are using the tendering process for the supply or manufacture of PPE.

The guidance is intended to ensure that these parties understand our regulatory requirements and that all products must comply with the stated standards, legislation and/or directives.

It includes advice for health and social care providers on the essential technical requirements and how these impact any existing PPE stocks, direct supply, donation or purchasing which they may now also be conducting or receiving outside of the national procurement model for PPE.

The following 3 pieces of guidance have been deleted as they are out of date:

1. Essential technical requirements for new high-volume manufacture of personal protective equipment (PPE) and medical devices (MD) during COVID-19
2. Essential technical requirements for PPE and medical devices: further information for manufacturers and suppliers
3. Essential technical requirements for PPE and medical devices: further information for health and social care providers

The guidance was intended for new and novel manufacturers to understand relevant performance requirements of medical devices and PPE, where they were intended to be supplied to healthcare for protection against the coronavirus disease and where the item had not undergone full conformity assessment.

This guidance has been withdrawn because regulatory easements are no longer available for PPE.

Any new PPE must satisfy the essential health and safety requirements of the 2016/425 PPE regulations and carry the CE or UKCA mark.

Medical devices must conform to UK MDR 2002 or EU MDR to use the UKCA or CE mark. For exceptional use cases please read MHRA guidance on exemptions from the Medical Device Regulations during the coronavirus outbreak.

Published 30 March 2020
Last updated 14 February 2022 + show all updates

1. 14 February 2022

   Updating the technical specification to address the issue of masks potentially touching the nose and mouth.

2. 25 January 2022

   In 'Transparent face mask technical specification', updated the visibility requirements so that anti-fogging coatings are not removed during testing.

3. 30 November 2021

   Deleted 'Essential technical requirements for new high-volume manufacture of personal protective equipment (PPE) and medical devices (MD) during COVID-19', 'Essential technical requirements for PPE and medical devices: further information for manufacturers and suppliers' and 'Essential technical requirements for PPE and medical devices: further information for health and social care providers' as they out of date.

4. 30 July 2021

   Updated section 5.10 of the Transparent face mask technical specification.

5. 1 April 2021

   Added new attachment: 'Transparent face mask technical specification'.

6. 28 August 2020

   Added the following 3 attachments:'Essential technical requirements for new high-volume manufacture of personal protective equipment (PPE) and medical devices (MD) during COVID-19', 'Essential technical requirements for PPE and medical devices: further information for manufacturers and suppliers' and 'Essential technical requirements for PPE and medical devices: further information for health and social care providers'. These replaced 2 existing guidance documents, 2 technical specification documents and 4 apron documents.

7. 11 May 2020

   Accessible documents uploaded.

8. 5 May 2020

   Version 3 of Essential Technical Specifications replacing version 2.

9. 5 May 2020

   We have attached new documentation and amended the details section to reflect.

10. 6 April 2020

    Additional attachments added

11. 3 April 2020

    Removed attachments

12. 3 April 2020

    Additional upload of documentation.

13. 30 March 2020

    First published.