二类医疗器械都包括哪些 标准查询与下载
共找到 150 条与 二类医疗器械都包括哪些 相关的标准，共 10 页
NASA extends coverage of nonprocurement suspension and debarment requirements beyond first-tier procurementcontracts under a covered nonprocurement
Grants and Agreements. Part1880:Nonprocurement debarment and suspension. Section1880.220:What contracts and subcontracts, in addition to those listed in 2 CFR 180.220, are covered transactions?
Service Specifications for Class II Medical Device Registration
Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
Les normes CSA font 'objet de revisions périodiques et des modifications aux Exigences propres au Canada sont publiées au besoin sous forme de
Medical Devices - Application of Risk Management to Medical Devices second edition
MEDICAL DEVICE CLASSIFICATION PROCEDURES
MEDICAL DEVICE CLASSIFICATION PROCEDURES
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device
Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Full Description ISO 13485:2016 Plus Redline specifies requirements for a quality management system that can be used
Medical devices - Quality management systems - Requirements for regulatory purposes (includes Redline Version)
(a) You must submit to us an annual report on FDA Form 3419, or electronic equivalent as approved by us under § 803.14. You must submit an annual
Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产，或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程，但其他过程操作也能
Packaging for terminally sterilized medical devices
Medical instruments - Packaging - Technical specification
本文件规定了可灭菌医疗器械包装膜（以下简称：包装膜）的产品分类、要求、试验方法、检验规则、标识标志、包装、运输、贮存等
Sterilizable packaging films for medical devices
1 Prezentul standard stabile?te clasificarea ?i terminologia specific? instrumentelor medi-cale de uz uman. 2 Instrumentul medical este o pies
MEDICAL INSTRUMENTS Clasification and terminology
Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
See Danish scope
Standards package - Medical devices - Basic standards
