ANSI/AAMI ST15883-1:2009(R2023)
Current
The latest, up-to-date edition.
Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
Hardcopy , PDF
English
03-04-2023
This part of ISO 15883 specifies 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.
| DocumentType |
Standard
|
| ISBN |
9781570203657
|
| Pages |
130
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| BS 2745-3:1993 | Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry |
| IEC 60073:1996 | Basic and safety principles for man-machine interface, marking and identification - Coding principles for indication devices and actuators |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 14698-1:2003 | Cleanrooms and associated controlled environments — Biocontamination control — Part 1: General principles and methods |
| ISO 9000:2005 | Quality management systems — Fundamentals and vocabulary |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| BS 2745-2:1993 | Washer-disinfectors for medical purposes Specification for human waste container washer-disinfectors |
| ISO 13485:2003 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 9001:2000 | Quality management systems — Requirements |
| DIN 10510:2013-10 | Food hygiene - Commercial dishwashing with multitank-transportdishwashers - Hygiene requirements, procedure testing |
| ISO 10993-1:1992 | Biological evaluation of medical devices — Part 1: Guidance on selection of tests |
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