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
06-27-2017
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 |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| ISO 9237:1995 | Textiles — Determination of the permeability of fabrics to air |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| EN ISO 9237:1995 | Textiles - Determination of permeability of fabrics to air (ISO 9237:1995) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| EN 14065:2016 | Textiles - Laundry processed textiles - Biocontamination control system |
| ISO 22612:2005 | Clothing for protection against infectious agents Test method for resistance to dry microbial penetration |
| EN 29073-3:1992 | Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation |
| EN ISO 13938-1:1999 | Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11092:2014 | Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) |
| ISO 9073-10:2003 | Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state |
| EN ISO 9073-10:2004 | Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) |
| ISO 139:2005 | Textiles — Standard atmospheres for conditioning and testing |
| ISO 13938-1:1999 | Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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