GB/T 16886.11-1997
Replaced
T/ZAMEI 6-2024
Active
Group standards
T/ZAMEI 6-2024 Blood dialysis machine maintenance and service specification
T/ZAMEI 6-2024 Blood dialysis machine maintenance and service specification
Price:
$ 20.00
Basic Information
Standard Code:
T/ZAMEI 6-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Integrated medical equipment
Publish Date:
2024-12-12
Implement Date:
2025-01-01
Scope
Scope: This document specifies the terms and definitions, technical requirements, file management, and service satisfaction feedback for the maintenance and repair services of hemodialysis equipment (hereinafter referred to as hemodialysis machines). This document is applicable to the installation, repair, maintenance, quality control, and technical support of hemodialysis machines. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Technical requirements 4.1 General provisions 4.2 Information disclosure 4.3 Requirements for service units 4.4 Requirements for service personnel 4.5 Requirements for maintenance parts 4.6 Facilities, equipment, and environment 4.7 Installation 4.8 Maintenance 4.9 Complaints and handling 5. File management 6. Service satisfaction feedback
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