AS 1807:2021 Separative devices – Biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators一 Methods of test

AS 1807:2021 Separative devices – Biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators一 Methods of test. This document specifies requirements and test methods for the testing of separative devices, comprising biological and cytotoxic drug safety cabinets, clean workstations and pharmaceutical isolators. The testing methods can be applied on any manufactured product that meets the requirements of AS 2252 Parts 1 to 6 and AS 4273. This document can also be used for other items of equipment that are used as a separative device in critical applications. NOTE For testing of clean rooms, see AS ISO 14644.3. 1.2 Application The methods of test can be applied to separative devices within any work place environment. Where separative devices are not manufactured in accordance with this document (e.g. imported products), testing to this document may be suitable for the purposes of claims of conformance to an Australian Standard. 1.3 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document: NOTE Documents referenced for in formative purposes are listed in the Bibliography. AS 1259.1, Acoustics—Sound level meters, Part 1: Non-integrating AS 2252 (series), Controlled environments AS 4260, High efficiency particulate air (HEPA) filters—Classification, construction and performance AS 4273, Design, installation and use of pharmaceutical isolators AS ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration AS ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories IEC 60051-1, Direct acting indicating analogue electrical measuring instruments and their accessories, Part 1: Definitions and general requirements common to all parts IEC 60051-2, Direct acting indicating analogue electrical measuring instruments and their accessories, Part 2: Special requirements for ammeters and voltmeters 1.4 Terms and definitions 1.4.1 aerosol challenge challenging an installed HEPA filter by test aerosol 1.4.2 casing housing that provides mechanical protection for housing the media, provides structural rigidity, and ability for clamping or sealing the assembled filter into place 1.4.3 competent person person who has acquired, through education, training, qualification or experience or a combination of these, the knowledge and skill enabling that person to perform the test methods, and have knowledge of hazardous materials and experience in mechanical trades Note 1 to entry: AS ISO/IEC 17025 provides conformity assessment requirements for laboratories that may be engaged to carry out calibration and testing. 1.4.4 filtration...