Ini adalah the equipment pasukan petugas, satu ruang untuk kerjasama di kalangan ahli Wikipedia. Peserta baru dialu-alukan; Anda bebas untuk menyertai!
Piawaian ISO untuk ujian dan pembuatan PPE dan tindak balas kecemasan COVID-19 (tersedia secara percuma di sini):
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ISO 374-5:2016, Sarung tangan pelindung daripada bahan kimia berbahaya dan mikro-organisma - Bahagian 5: Istilah terminologi dan prestasi untuk risiko mikro-organisma
ISO 10651-3:1997, Ventilator paru-paru untuk penggunaan perubatan - Bahagian 3: Keperluan khusus untuk ventilator kecemasan dan pengangkutan
ISO 10651-4:2002, Ventilator paru-paru - Bahagian 4: Keperluan khusus untuk resusitasi yang bertenaga operator
ISO 10651-5:2006, Ventilator paru-paru untuk penggunaan perubatan - Keperluan khusus untuk keselamatan asas dan prestasi penting - Bahagian 5: Resusitasi kecemasan bertenaga gas
ISO 10993-1:2018, Penilaian biologi alat perubatan - Bahagian 1: Penilaian dan pengujian dalam proses pengurusan risiko
ISO 13485:2016, Peranti perubatan - Sistem pengurusan kualiti - Keperluan untuk tujuan peraturan
ISO 17510:2015, Alat perubatan - Terapi pernafasan apnea tidur - Topeng dan aksesori aplikasi
ISO 18082:2014, Peralatan anestetik dan pernafasan - Dimensi penyambung tekanan rendah berulir-skru (NIST) yang tidak boleh ditukar ganti untuk gas perubatan [Termasuk ISO 18082:2014/AMD 1:2017, AMENDMENT 1]
ISO 18562-1:2017, Penilaian biokompatibiliti saluran gas pernafasan dalam aplikasi penjagaan kesihatan - Bahagian 1: Penilaian dan pengujian dalam proses pengurusan risiko
ISO 18562-2:2017, Penilaian biokompatibiliti saluran gas pernafasan dalam aplikasi penjagaan kesihatan - Bahagian 2: Ujian untuk pelepasan bahan zarah
ISO 18562-3:2017, Penilaian biokompatibiliti saluran gas pernafasan dalam aplikasi penjagaan kesihatan - Bahagian 3: Ujian untuk pelepasan sebatian organik yang mudah menguap (VOCs)
ISO 18562-4:2017, Penilaian biokompatibiliti saluran gas pernafasan dalam aplikasi penjagaan kesihatan - Bahagian 4: Ujian untuk kebolehlekatan dalam kondensat
ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics
ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for nucleic acid target sequences — qPCR and dPCR
ISO 22301:2019, Security and resilience – Business continuity management systems –Requirements
ISO 22395:2018, Security and resilience – Community resilience – Guidelines for supporting vulnerable persons in an emergency
ISO 22320:2018, Security and resilience – Emergency management – Guidelines for incident management
ISO 22316:2017, Security and resilience – Organizational resilience – Principles and attributes
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 80601-2-12:2020, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
ISO 80601-2-13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: ISO 80601-2-13:2011/Amd.1:2015, AMENDMENT 1 and ISO 80601-2-13:2011/Amd.2:2018, AMENDMENT 2]
ISO 80601-2-70:2015, Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
ISO 80601-2-79:2018, Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
ISO 80601-2-80:2018, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
ISO/TS 16976-8:2013, Respiratory protective devices — Human factors — Part 8: Ergonomic factors
ASTM Standards for PPE testing and manufacturing (freely available here):
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ASTM F2299/F2299M-03(2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
ASTM F1494-14 Standard Terminology Relating to Protective Clothing
ASTM F2407 - 06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
ASTM F1671 / F1671M - 13 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F1868 - 17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ASTM D751 - 19 Standard Test Methods for Coated Fabrics
ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
ASTM D1776/D1776M-20 Standard Practice for Conditioning and Testing Textiles
ASTM D5034-09(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D5733 - 99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
ASTM D6701-16 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
ASTM F1494-14 Standard Terminology Relating to Protective Clothing
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D3578-19 Standard Specification for Rubber Examination Gloves
ASTM D5250-19 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
ASTM E2755-15 Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
ASTM E1174-13 Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
ASTM E3058-16 Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
ASTM F3387-19 Standard Practice for Respiratory Protection
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