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Notice of Intent
Processing of health care products - Information...
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile...
Notice of Intent
PROCESSING OF HEALTH CARE PRODUCTS — INFORMATION...
This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is...
Notice of Intent
Sterilization of health care products - Microbiological...
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package...
Notice of Intent
WASHER-DISINFECTORS - PART 5: TEST SOILS AND ...
This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
Notice of Intent
Requirements for the design, development, and...
1.1 General This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and...
Notice of Intent
Guide for kVA sizing of dry-type transformers...
1.1 The Guide applies to all 1.2 kV class dry -type transformers covered under CSA C22.2 No. 47 and CSA C9 for commercial and industrial applications. 1.2 The Guide is not intended to apply to transformers applying specialty...
Notice of Intent
Sterilization of health care products — Chemical...
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose...
Notice of Intent
Sterilization of health care products — Chemical...
This part of ISO 11140 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads)...
Notice of Intent
Sterilization of health care products — Chemical...
This part of ISO 11140 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam...
Notice of Intent
Sterilization of health care products — Biological...
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low...
Notice of Intent
Safe use of energy based medical and surgical...
Note: The title and scope for this NOI (originally published on February 14, 2023) were updated by the responsible SDO on April 23, 2024. 1.1 This Standard applies to the use of energy based medical and surgical devices...
Notice of Intent
Ceramic plumbing fixtures
1.1 This Standard covers vitreous and non-vitreous china plumbing fixtures and specifies requirements for materials, construction, performance, testing, and markings. This Standard’s performance requirements and test...