Name: BS EN ISO 15883-1 : 2009
Brand: BSI

BS EN ISO 15883-1 : 2009

Superseded

View Superseded by

WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)

Superseded date

08-29-2020

Published date

01-01-2009

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and process requirements
6 Testing for conformity
7 Documentation
8 Information to be supplied by the manufacturer
9 Marking, labelling and packaging
10 Information to be requested from the purchaser by the
   supplier of the WD
Annex A (informative) - Test programme
Annex B (informative) - A[O] concept - Comparative lethality
                        of moist heat processes
Annex C (normative) - Test methods for the detection and
                      assessment of residual proteinaceous
                      contamination
Annex D (normative) - Microbiological recovery medium for
                      estimation of bacterial contamination
                      of water
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC on medical
                         devices

Describes general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

Committee	LBI/35
DevelopmentNote	Supersedes BS 2745-1(1993) (05/2006) Supersedes 99/124125 DC. (06/2006) 2009 Editon Re-issued in September 2014 & incorporates AMD 1 2014. Supersedes 12/30252545 DC. (09/2014)
DocumentType	Standard
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 15883-1:2009+A1:2014
Supersedes	12/30252545 DC : 0 99/124125 DC : DRAFT NOV 1999 BS 2745-1:1993

Standards	Relationship
SN EN ISO 15883-1 : 2009 AMD 1 2014	Identical
UNI EN ISO 15883-1 : 2014	Identical
DIN EN ISO 15883-1:2014-10	Identical
NF EN ISO 15883-1 : 2009 AMD 1 2014	Identical
NS EN ISO 15883-1 : 2009 AMD 1 2014	Identical
I.S. EN ISO 15883-1:2009	Identical
EN ISO 15883-1:2009/A1:2014	Identical
NBN EN ISO 15883-1 : 2009 AMD 1 2014	Identical
NEN EN ISO 15883-1 : 2009 AMD 1 2014	Identical
ISO 15883-1:2006	Identical
UNE-EN ISO 15883-1:2009	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 285:2015	Sterilization - Steam sterilizers - Large sterilizers
IEC 60073:2002	Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 15883-3:2006	Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 1717:2000	Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
ISO 12100:2010	Safety of machinery — General principles for design — Risk assessment and risk reduction
ISO/TS 15883-5:2005	Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 14698-1:2003	Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
ISO 14644-3:2005	Cleanrooms and associated controlled environments Part 3: Test methods
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 15883-4:2008	Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 13849-2:2012	Safety of machinery — Safety-related parts of control systems — Part 2: Validation
DIN 58955-3:1998-09	DECONTAMINATION-APPARATUS IN THE MEDICAL FIELD - EFFICIENCY TESTING
IEC 80416-1:2008	Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
IEC 60751:2008	Industrial platinum resistance thermometers and platinum temperature sensors
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
EN 1822-1:2009	High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
IEC 61508-1:2010	Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
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.
DIN 10510:2013-10	FOOD HYGIENE - COMMERCIAL DISHWASHING WITH MULTITANK-TRANSPORTDISHWASHERS - HYGIENE REQUIREMENTS, PROCEDURE TESTING
IEC 60584-1:2013	Thermocouples - Part 1: EMF specifications and tolerances
ISO 228-1:2000	Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices