SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS

Published date

27-06-2017

Publisher

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 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 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 31092:1993/A1:2012	TEXTILES - DETERMINATION OF PHYSIOLOGICAL PROPERTIES - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED - HOTPLATE TEST) (ISO 11092:1993/AMD 1:2012)
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
EN ISO 139:2005/A1:2011	Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)
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
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)