YY/T 0708-2009 English PDF (YYT0708-2009)

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YY/T 0708-2009: Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems
YY/T 0708-2009
Medical electrical equipment-Part 1-4. General requirements for safety.Collateral standard. Programmable electrical medical systems
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical electrical equipment. Part 1-4. General safety requirements
Parallel Standard. Programmable Medical Electrical System
Released on.2009-11-11
2010-12-12-01 implementation
Published by the State Food and Drug Administration
Foreword
This collateral standard is equivalent to IEC 60601-1-4..2000 "Medical Electrical Equipment Part 1-4. General requirements for safety.
Programmable Medical Electrical System.
This collateral standard is GB 97.16.1-2007 "Medical Electrical Equipment Part 1. General Safety Requirements" (IEC 60601-1. 1988,
IDT) A juxtaposition of common standards.
Appendix AAA of this collateral standard is a normative appendix, Appendix BBB, Appendix CC, Appendix DDD, Appendix EEE, Appendix FFF are all
It is an informative appendix.
This collateral standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee (SAC/TC10).
This juxtaposed standard was drafted by. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, National Wuhan Medical Supervision
Acoustic Instrument Quality Supervision and Testing Center.
The main drafters of this collocated standard. Du Yan, Ma Li, He Anshi, Zheng Jian.
introduction
Computers are increasingly used in medical electrical equipment and often play a role closely related to safety. Computer Application Technology in
The use of medical electrical equipment makes the complexity of the system second only to the diagnosis and/or treatment of medical equipment --- the patient's physiology department
System. This complexity means that systemic failures may exceed the ability to be judged by practically acceptable test limits. Accordingly, intrinsic safety
The full standard goes beyond the traditional testing and evaluation of existing medical electrical equipment; this safety standard includes requirements for the medical device development process.
The finished product test itself cannot fully explain the safety of complex medical electrical equipment.
This document is a juxtaposition of common standards. It requires following a process and producing a record of the process to support the
Sub-system safety of medical electrical equipment. The concepts of risk management and development life cycle are the foundation of the standard, and these concepts
It is also valuable to develop medical electrical equipment without programmable electronic subsystems.
For the task to be handled, the effective application of this standard requires the following capabilities.
--- Safety factors that should be considered in specific medical electrical equipment applications;
--- The development process of medical electrical equipment;
--- security guarantee method;
--- Risk analysis and risk control skills.
Medical electrical equipment. Part 1-4. General safety requirements
Parallel Standard. Programmable Medical Electrical System
First overview
1 Scope, purpose, and relationship with other standards
1.2001 range
This collateral standard applies to medical electrical equipment and medical electrical systems with programmable electronic subsystems (PESS) [hereinafter referred to as
Programming Medical Electrical Systems (PEMS)] safety requirements.
Note. Some systems with software for medical purposes are beyond the scope of this collateral standard, for example. many medical information systems. Identification elements (criteria)
For. Does the system meet the definition of medical electrical equipment in GB 2.706.1-2.07 or 2.2.1 in GB 2.706.15-2008?
Definition of medical electrical systems.
1.202 Purpose
This collateral standard specifies requirements in the design of programmable medical electrical systems. This collateral standard is also used as the basis for the requirements of specific standards.
Foundations, including guidance on security requirements for risk reduction and management purposes. This collateral standard addresses.
a) certification body;
b) the manufacturer;
c) Special standard preparation staff.
This standard covers.
d) requirements specifications;
e) architecture;
f) detailed design and implementation, including software development;
g) modification;
h) verification and validation;
i) Marking and random files.
This standard does not cover.
ii) hardware manufacturing;
k) software replication;
l) installation and delivery;
m) operation and maintenance;
n) Exit use.
1.203 Relationship with other standards
1.203.1 GB 970.1
For medical electrical equipment, this collateral standard is a supplement to GB 97.16.1.
When quoting GB 9706.1 or this juxtaposed standard separately or jointly, it is clear as follows.
--- "This General Standard" refers only to GB 976.1;
--- "This juxtaposed standard" refers only to ＹＹ/T 0708-2009;
--- "This standard" refers to the general standard and this juxtaposed standard.
1.203.2 Special standards
The requirements in the dedicated standard take precedence over the corresponding requirements in this collateral standard.
1.203.3 Normative references
The clauses in the following documents have been incorporated into the clauses of this standard by reference. For dated references, their
All subsequent amendments (excluding the content of errata) or revisions are not applicable to this collateral standard, however, it is encouraged that
The parties to the agreement study whether the latest versions of these documents are available. For undated references, the latest edition applies to this document.
Tied standards.
GB 970.1-2007 Medical electrical equipment Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.15-2008 Medical electrical equipment. Part 1-1. General requirements for safety. Collateral standard. Safety for medical electrical systems.
Requirements (IEC 60601-1-1..2000, IDT)
GB/T.1990-2000 Quality Management System Requirements (idt ISO 9001..2000)
IEC 60878. 1984 Medical Radiology Terminology
2.2001 Terms and Definitions
The following terms and definitions apply to this collateral standard. In this juxtaposed standard, terms used in bold typeface and common standards,
GB 9706.15 is consistent with the definitions in this collateral standard or IEC 60878. 1984.
This collateral standard gives an index of terms in Appendix AAA (normative appendix).
2.201.1.1
Necessary activities from the conceptual design phase of the project to the completion of the verification of the programmable medical electrical system (PEMS).
2.201.2
Identification of hazards and causes.
Note. Quantification of hazards is not part of the hazard analysis.
2.201.3
Specify the maximum acceptable amount of risk.
Note. The amount of risk can be either the regulation of the entire hazard of a programmable medical electrical system, or the regulation of a specific hazard.
2.201.4
Medical electrical equipment or medical electrical system containing one or more programmable electronic subsystems.
2.201.5
Systems based on one or more central processing units, including their software and interfaces.
2.201.6
After implementing risk management, the remaining risks are derived from the hazard analysis.
2.201.7
Probability of harm causing harm and severity of harm.
2.201.8
The part of the quality record required by this standard.
2.201.9
Provide traceab...