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BSI
17/30358661 DC : 0

17/30358661 DC : 0

NA

NA

Status of Standard is Unknown

BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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

BS EN 13795-2.

Committee
CH/205/1
DocumentType
Draft
Pages
31
PublisherName
British Standards Institution
Status
NA

Standards Relationship
PREN 13795-2 : DRAFT 2017 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)

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Hardcopy - English
PDF - English
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