GB/T 16886.11-1997
Replaced
T/ZS 0723-2025
Active
Group standards
T/ZS 0723-2025 Specification for acceptance of medical equipment in healthcare institutions
T/ZS 0723-2025 Specification for acceptance of medical equipment in healthcare institutions
Price:
$ 20.00
Basic Information
Standard Code:
T/ZS 0723-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Integrated medical equipment
Publish Date:
2025-08-18
Implement Date:
2025-08-25
Scope
Preface 1 Scope 2 Normative Reference Documents 3 Terms and Definitions 4 Basic Requirements 4.1 General Provisions 4.2 Requirements for Acceptance Personnel 4.3 Requirements for Use (Environment/Conditions) 4.4 Commercial Acceptance 4.5 Technical Acceptance 4.6 Operational Training 4.7 Establishing Archives and Ledgers 5 Acceptance Procedures and Requirements 5.1 Overview 5.2 Verification of Equipment Installation Site 5.3 Commercial Acceptance 5.4 Technical Acceptance 5.5 Clinical Acceptance 5.6 Operational Training 5.7 Establishing Archives and Ledgers 5.8 Claims Appendix A (Informative) Related Normative Forms Appendix B (Informative) Medical Device Classification Table Appendix C (Informative) Medical Device Technical Acceptance Report Appendix D (Informative) Medical Device Archive Collection Details References
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced