PREN 13795-1 : DRAFT 2017
Current
The latest, up-to-date edition.
SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
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) - Rationales
Annex C (informative) - Information on further characteristics
Annex D (informative) - Environmental aspects
Annex E (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 concerning manufacturing and processing requirements.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| 17/30358658 DC : 0 | Identical |
| 17/30358658 DC : DRAFT JUN 2017 | Identical |
| 02/712046 DC : DRAFT OCT 2002 | ISO 11810-1 - OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER RELATED EQUIPMENT - TEST METHODS AND CLASSIFICATION FOR LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PRIMARY IGNITION |
| 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) |
| EN 20811:1992 | Textiles - Determination of resistance to water penetration - Hydrostatic pressure test |
| EN ISO 9073-11:2004 | Textiles - Test methods for nonwovens - Part 11: Run-off (ISO 9073-11:2002) |
| ISO 9237:1995 | Textiles — Determination of the permeability of fabrics to air |
| ISO 9073-12:2002 | Textiles — Test methods for nonwovens — Part 12: Demand absorbency |
| 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 |
| ISO 11810:2015 | Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Primary ignition, penetration, flame spread and secondary ignition |
| EN ISO 10993-10:2013 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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 ISO 11810:2015 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015) |
| 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 |
| EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
| ISO 11092:2014 | Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) |
| ISO 9073-11:2002 | Textiles — Test methods for nonwovens — Part 11: Run-off |
| ISO 9073-10:2003 | Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state |
| EN ISO 9073-6:2003 | Textiles - Test methods for nonwovens - Part 6: Absorption (ISO 9073-6:2000) |
| 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 15797:2002 | Textiles Industrial washing and finishing procedures for testing of workwear |
| 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 |
| EN ISO 9073-12:2004 | Textiles - Test methods for nonwovens - Part 12: Demand absorbency (ISO 9073-12:2002) |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 9073-6:2000 | Textiles — Test methods for nonwovens — Part 6: Absorption |
| EN ISO 22612:2005 | Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.