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CAN/CSA-ISO 15883-7:17

Current
Current

The latest, up-to-date edition.

Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical 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
Bibliography

Defines the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items.

This is the first edition of CAN/CSA-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, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15883-7 (first edition, 2016-02-01). Scope This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance. Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

DocumentType
Standard
ISBN
978-1-4883-1180-2
Pages
51
PublisherName
Canadian Standards Association
Status
Current

Standards Relationship
ISO 15883-7:2016 Identical

IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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
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)
EN 10088-2:2014 STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
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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