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1.1 This guide provides considerations for validating cleaning processes for medical devices during initial fabrication and assembly prior to initial use. Validated cleaning processes are important for achieving consistency in function and consistency in biocompatibility. The considerations...
This International Standard specifies the test methods of the validation and the performance of the distribution packaging for medical devices that do not need sterilization. This document is intended to facilitate harmonized regulatory requirements for transport packaging of...
This Protocol is intended to cover certification of drug testing sample collection and security equipment, including urine, whole blood, and serum blood sample collection, and encompasses required testing methods, design, and material requirements for this equipment. This Protocol...
This document specifies safety requirements relating to the materials, construction, performance, packaging and product information for drinking equipment intended for children of 0 to 48 months (see B.2) of age: - Re-usable containers and re-usable drinking accessories; - Single-use...
This part of 82079 International Standard provides principles and general requirements for information for the use of products. Information for use is: • necessary for the safe use of a product; • helpful for the efficient and effective use of a product; and • often necessary to fulfil market,...
Commented versions are a valuable improvement upon the conventional IEC Redline Version (RLV). These versions are designed to facilitate a clearer understanding of the revisions made between the prior and current editions of a publication. This enhanced product package incorporates both the...
This document specifies requirements for the provision and operation of indirect, temperature-controll
This document specifies requirements for the provision and operation of indirect, temperature-controll
This document specifies the requirements for valve protection caps, valve guards and shrouds used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps, valve guards or shrouds are some of the options available to protect cylinder valves (including Valves with Integral...
This standard applies to mechanical refrigeration equipment consisting of an integrated single package refrigeration unit, or separate unit cooler and condensing unit sections, where the condensing section can be located either outdoor or indoor. Controls may be integral, or can be...
This document specifies the requirements for valve protection caps and valve guards used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps and valve guards are some of the options available to protect cylinder valves, including valves with integral pressure regulators...
