PREN 13795-2 : DRAFT 2017
Current
The latest, up-to-date edition.
SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS
27-06-2017
European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Manufacturing and processing requirements
and documentation
6 Information to be supplied with the product
Annex A (normative) - Testing
Annex B (informative) - Design and testing of a
clean air suit
Annex C (informative) - Environmental aspects
Annex D (informative) - Guidance to users for
selecting products
Annex ZA (informative) - Relationship between
this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Bibliography
Defines information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| 17/30358661 DC : 0 | Identical |
| 17/30358661 DC : DRAFT JUNE 2017 | Identical |
| 02/565153 DC : DRAFT DEC 2002 | Identical |