AAMI-PROC-2007.pdf
《AAMI-PROC-2007.pdf》由会员分享,可在线阅读,更多相关《AAMI-PROC-2007.pdf(90页珍藏版)》请在三一文库上搜索。
1、AAMI Order Code: AAMIProc AAMI STANDARDS PROGRAM National and International (U.S. TAG) Policies and Procedures Manuals Hints on navigating this document: If you have the WORD version, turn on your “document map” to see a complete table of contents at left. Cross-references are hyperlinked. If you ha
2、ve the PDF version, use the bookmarks or table of contents. Cross-references are hyperlinked. Association for the Advancement of Medical Instrumentation 1110 N Glebe Road, Suite 220, Arlington, VA 22201-4795 Ph: 703-525-4890, ext. 250 Fax: 703-276-0793 email: standardsaami.org Internet: www.aami.org
3、 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 08/06/2007 22:59:35 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by the Associatio
4、n for the Advancement of Medical Instrumentation 1110 N Glebe Road Suite 220 Arlington, VA 22201-4795 Copyright 1992, 1996, 1999, 2002, 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Blank forms included in this publication - annexes A, B, and C - may be p
5、hotocopied. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 08/06/2007 22:59:35 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page CO
6、NTENTS3 AAMI STANDARDS PROGRAM POLICIES AND PROCEDURES MANUAL .7 OBJECTIVES OF THIS MANUAL8 AAMI STANDARDS PROGRAM POLICIES AND PROCEDURES MANUAL.9 1. Program scope and organization9 1.1 Program scope . 9 1.2 Program objective 9 1.3 Program benefits 10 1.4 Types of technical committee documents 10 1
7、.4.1 General 10 1.4.2 Medical device standards 10 1.4.3 Recommended practices 10 1.4.4 American national standards. 10 1.4.5 Technical information reports. 10 1.4.6 Technology conference reports. 11 1.4.7 Other technical publications 11 1.5 Technical document format. 11 1.5.1 General 11 1.5.2 Metric
8、 Policy. 11 1.5.3 Patent policy 12 1.5.4 Commercial terms and conditions. 12 1.6 Program organization. 12 1.6.1 General 12 1.6.2 Technical committees 12 1.6.3 AAMI Standards Board. 12 1.6.3.1 General 12 1.6.3.2 Membership. 12 1.6.3.3 Terms. 12 1.6.3.4 Responsibilities . 13 1.6.4 AAMI Board of Direct
9、ors. 13 1.6.5 AAMI staff 13 1.6.6 AAMI Committee on Standards Strategy 13 2. Committee structure and operations.13 2.1 Purpose and scope of AAMI technical committees. 13 2.2 Committee (co)chairs. 14 2.2.1 General 14 2.2.2 Selection 14 2.2.3 Terms 14 2.2.4 Qualifications 14 2.2.5 Responsibilities. 15
10、 2.2.6 Termination of appointments 15 2.3 Committee membership. 15 2.3.1 Committee size 15 2.3.2 Voting members 16 2.3.2.1 Representative members and alternates. 16 2.3.2.2 Independent expert members. 16 2.3.3 Lack of dominance 16 2.3.4 Openness and diversity (“balance”) 17 2.3.5 Interest categories
11、 . 17 2.3.5.1 Producer 17 2.3.5.2 User. 17 2.3.5.3 General interest . 18 2.3.5.4 Categorization of membership associations 18 2.3.6 Selection 18 2.3.7 Term 18 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111100
12、1, User=Wing, Bernie Not for Resale, 08/06/2007 22:59:35 MDTNo reproduction or networking permitted without license from IHS -,-,- 2.3.8 Qualifications 18 2.3.9 Application process. 19 2.3.10 Refusal of membership . 19 2.3.11 Responsibilities. 20 2.3.12 Full disclosure. 20 2.3.13 Termination of memb
13、ership 20 2.3.14 Changes in corporate/ institutional representation 21 2.3.14.1 Change of representative. 21 2.3.14.2 Change in affiliation 21 2.3.14.3 Temporary designation of alternate. 21 2.3.15 Liaisons. 21 2.4 Transaction of committee business 22 2.4.1 General 22 2.4.2 Announcement of meetings.
14、 22 2.4.3 Conduct of meetings . 22 2.4.4 Public participation in meetings 23 2.4.4.1 Technical committee meetings 23 2.4.4.2 Closed meetings 23 2.4.5 Documentation of meetings 23 2.4.6 Distribution of documents. 23 2.4.7 Decisions subject to Standards Board approval 23 2.5 Executive boards 24 2.6 Wo
15、rking groups and task groups. 24 2.6.1 Scope of work . 24 2.6.2 Working groups. 24 2.6.3 Task groups. 24 2.7 Project leaders . 24 2.7.1 Appointment 24 2.7.2 Project leader development of the draft document 25 2.7.3 Project leader responsibility through comment period 25 2.7.4 Other project leader re
16、sponsibilities 25 2.8 Termination of committees 25 2.9 Inactive status of committees. 26 2.10 New technical work 26 2.10.1 Evaluation and approval of new work. 26 2.10.2 Criteria for establishing new committees or initiating new work 26 2.10.3 Initiating and obtaining authorization for establishing
17、new committees or new work 26 2.10.4 Waivers. 27 2.11 Annual review and evaluation 27 2.11.1 General 27 2.11.2 Time limits for completion of new standards, recommended practices, and technical information reports 27 2.11.3 Time limits for other projects 28 2.11.4 Periodic review of existing standard
18、s and recommended practices. 28 2.11.4.1 Documents maintained on a periodic basis . 28 2.11.4.2 AAMI-authored documents maintained on a continuous basis . 28 2.11.5 Periodic review of technical information reports 28 2.11.6 Withdrawal for cause 28 2.12 Committee funding. 29 2.12.1 General 29 2.12.2
19、User travel funds. 29 2.12.3 Special projects. 29 3. Consensus and due process: Policies and procedures for the development of standards and recommended practices29 3.1 Development and due process . 29 3.2 Consensus 29 3.3 Due process . 30 3.3.1 Definition of due process 30 3.3.2 Openness. 30 3.3.3
20、Written procedures 30 3.3.4 Appeals . 30 3.3.5 Notice 30 4 2007 Association for the Advancement of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale,
21、 08/06/2007 22:59:35 MDTNo reproduction or networking permitted without license from IHS -,-,- 3.3.6 Consideration of views and objections 30 3.3.7 Records . 31 3.4 Key concepts underlying AAMI standards and recommended practices. 31 3.4.1 Fundamental concepts. 31 3.4.2 Performance criteria 31 3.4.3
22、 Rationale. 31 3.4.4 Verification of compliance 32 3.5 The development process for standards and recommended practices 32 3.5.1 General 32 3.5.2 Announcement of new committee or new work project 32 3.5.3 Initiation of work 33 3.5.4 Drafting stages 34 3.5.4.1 Preparing the first draft 34 3.5.4.2 Comm
23、ittee review of the draft (Working Draft stage). 34 3.5.5 Committee refinement of the draft (Committee Draft) 35 3.5.6 Formal Consensus Development (Proposed Draft stage) 36 3.5.6.1 General 36 3.5.6.2 Deadlines falling on a holiday or weekend . 36 3.5.6.3 Formal committee ballot 36 3.5.6.4 Public re
24、view. 39 3.5.6.5 Handling of late comments and comments unrelated to the proposal . 39 3.5.6.6 Response to ballot and public comments. 40 3.5.7 Final approval . 41 3.5.7.1 Notice to committee and public reviewers 41 3.5.7.2 Standards Board approval of final documents. 41 3.5.7.3 ANSI approval of fin
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- AAMI PROC 2007
链接地址:https://www.31doc.com/p-3728262.html