【国外标准】 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
本网站 发布时间:
2024-02-28
开通会员免费在线看70000余条国内标准,赠送文本下载次数,单本最低仅合13.3元!还可享标准出版进度查询、定制跟踪推送、标准查新等超多特权!  
查看详情>>
标准简介
适用范围:
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications.4.2 Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly, or through the US FDA master file program.1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, or other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.1.2 Fabrication and properties of elastomers is covered in the companion document, F2042. This monograph addresses only components of uncured elastomers, gels, and foams.1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ISO 9001 and current FDA Quality System Regulations/Good Manufacturing Practice Regulations (21CFR, Parts 210, 211, and 820).1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
标准号:
ASTM F2038-18
标准名称:
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
英文名称:
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials标准状态:
Active-
发布日期:
-
实施日期:
出版语种:
- 推荐标准
- 国家标准计划
- BS EN IEC 61753-082-02:2024 Fibre optic interconnecting devices and passive components. Performance standard
- BS ISO 5501-2:2024 Tobacco heating systems. Definitions and standard conditions for aerosol generation and collection
- BS ISO 5501-3:2024 Tobacco heating systems. Definitions and standard conditions for aerosol generation and collection
- BS ISO 5501-1:2024 Tobacco heating systems. Definitions and standard conditions for aerosol generation and collection
- BS ISO 24138:2024 Information and documentation. International Standard Content Code (ISCC)
- 24/30492859 DC BS EN IEC 61753-1 Fibre optic interconnecting devices and passive components - Performance standard
- BS EN IEC 61753-071-02:2020+A1:2024 Fibre optic interconnecting devices and passive components. Performance standard
- 24/30491443 DC standard
- KS D ISO 9226 금속 및 합금의 부식-대기의 부식성-부식성 평가를 위한 표준 시험편의 부식 속도 결정
- KS B 0831 비파괴검사 — 초음파탐상검사 — 표준 시험편
- 24/30489392 DC BS EN IEC 62358 Ferrite cores. Standard inductance factor for gapped cores and its tolerance
- BS ISO 19848:2024 - TC Tracked Changes. Ships and marine technology. Standard data for shipboard machinery and equipment
- BS ISO 19848:2024 Ships and marine technology. Standard data for shipboard machinery and equipment
- BS IEC 61360-7:2024 Standard data element types with associated classification scheme
- 24/30487130 DC BS EN 50566:2017/A2:2024 Product standard to demonstrate the compliance of wireless communication