14/30235350 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 15883-7 - WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
Hardcopy , PDF
English
31-03-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical requirements and protocol requirements
6 Testing for conformity
7 Documentation
8 Information to be provided by the manufacturer
9 Marking, labelling and packaging
10 Information to be requested from the purchaser by
the manufacturer
Annex A (normative) - Summary of test programmes
Annex B (normative) - Methods for microbiological
evaluation of disinfection of liquid transport
system
Annex C (normative) - Tests for microbiological
contamination of post-disinfection rinse water
Annex D (normative) - Preparation and evaluation of indicators
for microbiological testing of the efficacy
of chemical disinfection of the load
Annex E (informative) - Examples of test locations for the
tests with biological indicators
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography
BS EN ISO 15883-7.
| Committee |
LBI/35
|
| DocumentType |
Draft
|
| Pages |
43
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| EN 13624:2013 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1) |
| ISO 15883-1:2006 | Washer-disinfectors — Part 1: General requirements, terms and definitions and tests |
| PREN 12054 : DRAFT 1995 | CHEMICAL DISINFECTANTS AND ANTISEPTICS - PRODUCTS FOR HYGIENIC AND SURGICAL HANDRUB AND HANDWASH - BACTERICIDAL ACTIVITY - TEST METHOD AND REQUIREMENTS (PHASE 2, STEP 1) |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 15883-6:2011 | Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment |
| ISO 15883-3:2006 | Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers |
| EN 14348:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) |
| ISO 11731-2:2004 | Water quality — Detection and enumeration of Legionella — Part 2: Direct membrane filtration method for waters with low bacterial counts |
| EN 10088-2:2014 | Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes |
| EN 12353:2013 | Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity |
| EN 13727:2012+A2:2015 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
| ISO/TS 15883-5:2005 | Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning efficacy |
| ISO 15883-4:2008 | Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes |
| EN 14476:2013+A1:2015 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1) |
| EN 1040:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
| ISO 15883-2:2006 | Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| EN 10088-1:2014 | Stainless steels - Part 1: List of stainless steels |
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