中国医疗标准(GBmedicalstandards)

中国医疗标准（GBmedicalstandards）

(GB medical standards)

ANSI | BS | DIN | EN | GB | ISO | JIS | NF | DIC

GB 15980-1995

Hygienic standard of

disinfection for single use

medical products

GB 16352-1996

Standards for -rays

radiation sterilization of

disposable medical

appliances

GB 16383-1996

Quality control standards

for radiation sterilization

of medical and hygienical

products

GB 16895.24-2005

7-710 :

-

Electrical installations of

buildings-Part 7-

710:Requirements for special

installations or locations-

Medical locations

GB 18278-2000

Sterilization of health care

products--Requirements for

validation and routine

control--Industrial moist

heat sterilization

GB 18279-2000

Medical devices--Validation

androutine control of

ethylene oxide sterilization

GB 18280-2000

Sterilization of healthcare

products--Requirement for

validation and routine

control--Radiation

sterilization

GB 18281.1-2000

1

:

Sterilization of health care

products--Biological

indicators--Part 1:General

GB 18281.2-2000

2

:

Sterilization of health care

products--Biological

indicators--Part

2:Biological indicators for

ethylene oxide sterilization

GB 18281.3-

3

Sterilization of health care

products--Biological

indicators--Part

2000 :

3:Biological indicators for moist heat sterilization

GB 18282.1-2000

1

:

Sterilization of health care

products--Chemical

indicators--Part 1:General

requirements

GB 18282.3-2009

3

BD

Sterilization of health care

products - Chemical

indicators - Part 3: Class 2

indicator systems for use in

the Bowie and Dick-type

steam penetration test

GB 18282.4-2009

4

BD

Sterilization of health care

products - Chemical

indicators - Part 4: Class 2

indicators as an alternative

to the Bowie and Dick-type

test for detection of steam

penetration

GB 18457-2001

Stainless steel needle

tubing for manufactureof

medical devices

GB 18466-2005

Discharge standard of water

pollutants for medical

organization

GB 19212.16-2005

16

Safety of power transformers

,power supply units and

similar devices -- Part 16:

Particular requirements for

isolating transformers for

the supply of medical

locations

GB 19217-2003

( )

Technical standard for

medical waste transport

vehicle

GB 19218-2003

( )

Technical standard for

medical waste incinerator

GB 24627-2009

-

Standard specification for

wrought nickel-titanium

shape memory alloys for

medical devices and surgical

implants

GB 4824-

(ISM)

Industrial scientific and

medical(ISM)radio-frequency

equipment--Electromagnetic

2004

disturbance characteristics--Limits

measurement

GB/T 10001.6-2006

6

Public information graphical

symbols for use on

sign Part 6: Symbols for

medical treatment and health

care

GB/T 15566.6-2007

6 :

Guidance system for public

information - Setting

principles and requirements

- Part 6: Medical site

GB/T 16886.1-2001

1 :

Biological evaluation of

medical devices--Part

1:Evaluation and testing

GB/T 16886.10-2005

10 :

and methods of

Biological evaluation of

medical devices-Part

10:Tests for irritation and

delayed-type

hypersensitivity

GB/T 16886.11-1997

11 :

Biological evaluation of

medical devices--Part

11:Tests for systemic

toxicity

GB/T 16886.12-2005

12 :

Biological evaluation of

medical devices-Part

12:Sample preparation and

reference materials

GB/T 16886.13-2001

13 :

Biological evaluation of

medical devices--Part

13:Identification and

quantification of

degradation products from

polymeric medical devices

GB/T 16886.14-2003

14 :

Biological evaluation of

medical devices--Part

14:Identification and

quantification of

degradation products from

ceramics

GB/T 16886.15-2003

15 :

Biological evaluation of

medical devices--Part

15:Identification and

quantification of

degradation products from

metals and alloys

GB/T 16886.16-2003

16 :

Biological evaluation of

medical devices--Part 16:

Toxicokinetic study design

fordegradation products and

leachables

GB/T 16886.17-2005

17

Biological evaluation of

medical devices -- Part 17:

Establishment of allowable

limits for leachable

substances

GB/T 16886.2-2000

2 :

Biological evaluation of

medical devices--Part

2:Animal welfare

requirements

GB/T 16886.3-2008

3

Biological evaluation of

medical devices - Part 3:

Tests for

genotoxicity,carcinogenicity

and reproductive toxicity

GB/T 16886.4-2003

4 :

Biological evaluation of

medical devices--Part

4:Selection of tests for

interactions with blood

GB/T 16886.5-2003

5 :

Biological evaluation

ofmedical devices--Part 5:

Test for in vitro

cytotoxicity

GB/T 16886.6-1997

6 :

Biological evaluation of

medical devices--Part

6:Tests for local effects

after implantation

GB/T 16886.7-2001

7 :

Biological evaluation of

medical devices--Part

7:Ethylene oxide

sterilization residuals

GB/T 16886.9-2001

9 :

Biological evaluation of

medical devices--Part

9:Framework for

identification and

quantification of potential

degradation product

GB/T 17995-1999

Guidelines for

administrative medical and

nursing staffconcerned with

the safe use of medical

electrical equipment

GB/T 18773-2008

Environmental sanitation

standard for incineration of

medical treatment wastes

GB/T 1962.1-2001

6%(

) 1

:

The conical fittings with a

6%(Luer)taper for syringes

needles and certain other

medical equipment--Part

1:General requirement

GB/T 1962.2-2001

6%(

) 2

:

The conical fittings with a

6%(Luer)taper for syringes

needles and certain other

medical equipment--Part

2:Lock fittings

GB/T 19633-2005

Packaging for terminally

sterilized medical devices

GB/T 19702-2005

In vitro diagnostic medical

devices-Measurement of

quantities in samples of

biological origin-

Presentation of reference

measurement procedures

GB/T 19703-2005

In vitro diagnostic medical

devices-Measurement of

quantities in samples of

biological origin-

Description of reference

materials

GB/T 19971-2005

Sterilization of health care

products -- Vocabulary

GB/T 19972-2005

Sterilization of health care

products -- Biological

indicators --Guidance for

the selection, use and

interpretation of results

GB/T 19974-2005

Sterilization of health care

products -- General

requirement for

characterization of a

sterilizing agent and the

development ,validation and

routine

controlofasterilization

process for medical devices

GB/T

Sterilization of health care

products - Requirement for

validation and routine

20367-2006

control of moist heat sterilization in health care facilities

GB/T 21415-2008

In vitro diagnostic medical

devices - Measurement of

quantities in biological

samples - Metrological

traceability of values

assigned to calibrators and

control materials

GB/T 24628-2009

Sterilization of health care

products - Biological and

chemical indicators - Test

equipment

GB/T 24791.1-2009 X

/

1

Photography - Sensitometry

of screen/film systems for

medical X-radiography - Part

1: Determination of

sensitometric curve shape,

speed and average gradient

GB/T 24791.3-2009 X

/

3

X

()

GB/Z 18732-2002

Determination of limits for

industrial scientific and

medical equipment

GB/Z 19031-2009

Quality management systems -

Guidelines for process

improvements in health

service organizations

GB/Z 19511-2004

(ISM)

(ITU)

Industrial scientific and

medical equipment(ISM)--

Guidelines for emission

levels within the bands

designated by the ITU

GBZ 179-2006

Basic principles for

radiological protection of

medical exposure