GB/T 16886.23-2023Biological evaluation of medical devices - Part 23: Tests for irritation (English PDF)
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Issued by
Ministry of Industry and Information Technology of the People's Republic of China
Level / Type
National · Recommended
Issue date
July 14, 2015
Implementation date
January 1, 2016
Scope
GB/T 16886.23-2023 (Biological evaluation of medical devices - Part 23: Tests for irritation) is available as an English-translated PDF.
GB/T 16886.23-2023 — This Standard specifies the terms and definitions, classification and naming, requirements, test methods, inspection rules and marking, packaging, transport, storage for household and similar devices with ultra-violet disinfection of drinking water treatment unit.
This Standard applies to household and similar devices with ultra-violet disinfection of drinking water treatment unit and ultraviolet disinfection equipment of independent use.
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Document preview — GB/T 16886.23-2023
National Standard of the People's Republic of China
- ICS
- 97.180
- Classification
- Y 69
Issued by: Ministry of Industry and Information Technology of the People's Republic of China
Contents
- Foreword...3
- 1 Scope...4
- 2 Normative references...4
- 3 Terms and definitions...5
- 4 Classification and naming...6
- 5 Requirements...6
- 6 Test method...9
- 7 Inspection rules...12
- 8 Marks, packaging, transport, storage...15
Foreword
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This Standard was proposed by China Light Industry Federation.
This Standard shall be under the jurisdiction of National Technical Committee
on Household Appliances of Standardization Administration of China
(SAC/TC 46).
The drafting organizations of this Standard. Ningbo Hydrotek Co., Ltd.,
Zhejiang Patio Water Treatment Technology Co., Ltd., Beijing Origin Water
Pure Tech Co., Ltd., Qingdao Risheng Electric Service Co., Ltd., Zhongshan
Shide Light Industry Mechanical & Electrical Products Co., Ltd., China Quality
Inspection Association of Water Purification Equipment Professional
Committee, China Household Electrical Appliances Research Institute,
Changzhou Peide Water Treatment Equipment Co., Ltd., Lota (Xiamen)
Industrial Co., Ltd., Qingdao Jiesheng Electric Co., Ltd.
Main drafters of this Standard. Gu Chengtao, Peng Kaiqin, Wang Bing, Ji
Xiaojian, Zheng Jiandong, Gu Jiuchuan, Wang Tongshuai, Wu Zhiquan, Liao
Ronghua, She Dongtai.
This Standard was issued for the first time.
Household and similar devices with ultra-violet
disinfection of drinking water treatment unit
1 Scope
This Standard specifies the terms and definitions, classification and naming,
requirements, test methods, inspection rules and marking, packaging,
transport, storage for household and similar devices with ultra-violet
disinfection of drinking water treatment unit.
This Standard applies to household and similar devices with ultra-violet
disinfection of drinking water treatment unit and ultraviolet disinfection
equipment of independent use.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including
any amendments) applies.
GB/T 191, Packaging and storage marks
GB/T 1019, General requirements for the package of household and
similar electrical appliances
GB/T 2423.17, Environmental testing for electric and electronic products -
Part 2.Test method - Test Ka. Salt mist
GB/T 2828.1, Sampling procedures for inspection by attributes - Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection
GB 4706.1, Safety of household and similar electrical appliances; General
requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 drinking water treatment device
a system capable of improving water quality that consists of one or several
drinking water treatment units
3.2 ultra-violet disinfection
the process of using ultraviolet radiation of which the wavelength is 200nm ~
300 nm to kill the microorganisms or make the microorganisms lose activity
3.3 household and similar devices with ultra-violet disinfection of
drinking water treatment
using ultraviolet disinfection principle, as a component of household and
similar use of drinking water treatment device, hereinafter referred to as
"ultra-violet disinfection unit"
4 Classification and naming
4.1 Classification
4.2 Naming
5 Requirements
5.1 Normal use conditions
5.1.2 The environmental conditions are as follows.
a) temperature. 4°C ~ 40°C;
b) relative humidity. not greater than 90% (at 25°C).
5.2 Appearance
5.2.1 The ultra-violet disinfection unit shall look neat, without rust.
5.3 Materials
5.3.1 The material in contact with water shall meet requirements of GB/T
17219.
5.3.2 The metal material in contact with water shall be resistant to corrosion.
5.3.3 After plastic, rubber materials are subject to ultraviolet radiation, within
the nominal life of the material by the manufacturer, the material shall not be
deformed, softened, broken; the structure strength of the material shall meet
requirements of 5.4.2.The health and safety of the materials shall comply
with the requirements of 5.3.1.
5.4 Structure
5.4.1 The structural design shall be in rational layout and solid connection
for easy maintenance or replacement of ultra-violet lamp.
5.5 Health and safety
The health and safety of ultra-violet disinfection unit shall comply with the
requirements of GB/T 17219.
5.6 Effective dose of ultra-violet
The effective dose of ultra-violet in normal working of ultra-violet disinfection
unit shall not be less than 40 mJ/cm2.
5.9 Electrical safety
The electrical safety of ultra-violet disinfection unit shall meet requirements of
GB 4706.1.
5.10 Continuous service life
The continuous service life of ultra-violet disinfection unit shall not be less
than 5,000 h or the nominal value of manufacturer. During this time, the
effective dose of ultra-violet, disinfection effect and effluent quality of
ultra-violet disinfection unit shall meet requirements.
6 Test method
6.1 Test conditions
6.2 Appearance
Visual inspection.
6.3 Material
6.3.1 Carry out the detection according to the method specified in GB/T
17219.
6.3.2 The metal surface contact with water in the ultra-violet disinfection unit
shall be tested according to GB 2423.17.The test period is 96 h. The
sampling size 100 mm × 100 mm. Before the test, the surface shall be
cleaned and degreased. After the test, check the surface condition.
6.3.3 Light up the ultra-violet lamp for 24 h in the absence of water of
ultra-violet disinfection unit. Turn off the ultra-violet lamp and visually inspect
whether the structural material is deformed, damaged or softened. And carry
out the test according to 6.4.2 and the provisions of GB/T 17219.
6.4 Structure
6.4.2.3 Cycle pressure test
Carry out the cycle pressure test of ultra-violet disinfection unit according to
the following requirements.
6.5 Health and safety
Measure according to the method specified in GB/T 17219.
6.6 Effective dose of ultra-violet
Carry out the test according to the method specified in GB/T 19857.
6.7 Disinfection effect
6.7.1 Measure the disinfection effect of ultra-violet disinfection unit
according to the method specified in 4.2 of Ministry of Health, "Drinking Water
Disinfectant and Disinfection Equipment, Health and Safety Evaluation" (Trial)
(2001).
6.8 Effluent quality
Measure according to the method specified in GB/T 5750.
6.9 Electrical safety
Carry out the test according to the method specified in GB 4706.1.
6.10 Continuous service life
Carry out the draining test of ultra-violet disinfection unit according to the
nominal water flow of manufacturer. Carry out the timing till 5,000 h or the
nominal continuous service life of manufacturer (the larger value shall be
selected). Measure the effective dose of ultra-violet, disinfection effect and
effluent quality at this time according to the methods specified in 6.5, 6.6, 6.7.
7 Inspection rules
7.1 Inspection classification
The inspection consists of exit-factory inspection and type inspection.
7.2 Exit-factory inspection
7.2.4 The total number of effluent colonies and electrical safety projects in
the exit-factory inspection are fatal defects. As long as a piece fails to meet
the requirements, this batch of products shall be determined as unqualified.
7.3.4 The sample for type inspection shall be randomly extracted from the
exit-factory inspection qualified products. See Table 4 for sampling plan.
8 Marks, packaging, transport, storage
8.1 Marks
A nameplate shall be clearly marked on ultra-violet disinfection unit. The
following information shall be clearly marked on the nameplate.
8.2 Packaging
8.2.1 The packaging and storage marks shall conform to the provisions of
GB/T 191.
8.2.2 The packaging for the ultra-violet disinfection unit shall comply with
the provisions of GB/T 1019.
8.2.3 The outer surface of the box shall at least clearly indicate the following
information.
8.2.4 The following technical documents shall be attached to the packing
box.
8.3 Transport
The ultra-violet disinfection unit shall be fixed during the transport process to
avoid collision, fall, rain and moisture; shall not be pressed or inverted; shall
not be mixed with toxic and hazardous materials.
8.4 Storage
The ultra-violet disinfection unit shall be stored in a dry, ventilated place
without toxic or harmful items; shall not be pressed or inverted; shall avoid
long-term direct sunlight.
QB/T 4827-2015
GB
LIGHT INDUSTRY STANDARD
ICS 97.180
Y 69
Filing No.. 51124-2015
Household and similar devices with ultra-violet
disinfection of drinking water treatment unit
Issued on. JULY 14, 2015
Implemented on. JANUARY 1, 2016
Issued by. Ministry of Industry and Information Technology of the
People's Republic of China
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 5
4 Classification and naming... 6
5 Requirements... 6
6 Test method... 9
7 Inspection rules... 12
8 Marks, packaging, transport, storage... 15
Foreword
This Standard was drafted in accordance with the rules given in GB/T
1.1-2009.
This Standard was proposed by China Light Industry Federation.
This Standard shall be under the jurisdiction of National Technical Committee
on Household Appliances of Standardization Administration of China
(SAC/TC 46).
The drafting organizations of this Standard. Ningbo Hydrotek Co., Ltd.,
Zhejiang Patio Water Treatment Technology Co., Ltd., Beijing Origin Water
Pure Tech Co., Ltd., Qingdao Risheng Electric Service Co., Ltd., Zhongshan
Shide Light Industry Mechanical & Electrical Products Co., Ltd., China Quality
Inspection Association of Water Purification Equipment Professional
Committee, China Household Electrical Appliances Research Institute,
Changzhou Peide Water Treatment Equipment Co., Ltd., Lota (Xiamen)
Industrial Co., Ltd., Qingdao Jiesheng Electric Co., Ltd.
Main drafters of this Standard. Gu Chengtao, Peng Kaiqin, Wang Bing, Ji
Xiaojian, Zheng Jiandong, Gu Jiuchuan, Wang Tongshuai, Wu Zhiquan, Liao
Ronghua, She Dongtai.
This Standard was issued for the first time.
Household and similar devices with ultra-violet
disinfection of drinking water treatment unit
1 Scope
This Standard specifies the terms and definitions, classification and naming,
requirements, test methods, inspection rules and marking, packaging,
transport, storage for household and similar devices with ultra-violet
disinfection of drinking water treatment unit.
This Standard applies to household and similar devices with ultra-violet
disinfection of drinking water treatment unit and ultraviolet disinfection
equipment of independent use.
2 Normative references
The following referenced documents are indispensable for the application of
this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including
any amendments) applies.
GB/T 191, Packaging and storage marks
GB/T 1019, General requirements for the package of household and
similar electrical appliances
GB/T 2423.17, Environmental testing for electric and electronic products -
Part 2.Test method - Test Ka. Salt mist
GB/T 2828.1, Sampling procedures for inspection by attributes - Part 1.
Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection
GB 4706.1, Safety of household and similar electrical appliances; General
requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 drinking water treatment device
a system capable of improving water quality that consists of one or several
drinking water treatment units
3.2 ultra-violet disinfection
the process of using ultraviolet radiation of which the wavelength is 200nm ~
300 nm to kill the microorganisms or make the microorganisms lose activity
3.3 household and similar devices with ultra-violet disinfection of
drinking water treatment
using ultraviolet disinfection principle, as a component of household and
similar use of drinking water treatment device, hereinafter referred to as
"ultra-violet disinfection unit"
4 Classification and naming
4.1 Classification
4.2 Naming
5 Requirements
5.1 Normal use conditions
5.1.2 The environmental conditions are as follows.
a) temperature. 4°C ~ 40°C;
b) relative humidity. not greater than 90% (at 25°C).
5.2 Appearance
5.2.1 The ultra-violet disinfection unit shall look neat, without rust.
5.3 Materials
5.3.1 The material in contact with water shall meet requirements of GB/T
17219.
5.3.2 The metal material in contact with water shall be resistant to corrosion.
5.3.3 After plastic, rubber materials are subject to ultraviolet radiation, within
the nominal life of the material by the manufacturer, the material shall not be
deformed, softened, broken; the structure strength of the material shall meet
requirements of 5.4.2.The health and safety of the materials shall comply
with the requirements of 5.3.1.
5.4 Structure
5.4.1 The structural design shall be in rational layout and solid connection
for easy maintenance or replacement of ultra-violet lamp.
5.5 Health and safety
The health and safety of ultra-violet disinfection unit shall comply with the
requirements of GB/T 17219.
5.6 Effective dose of ultra-violet
The effective dose of ultra-violet in normal working of ultra-violet disinfection
unit shall not be less than 40 mJ/cm2.
5.9 Electrical safety
The electrical safety of ultra-violet disinfection unit shall meet requirements of
GB 4706.1.
5.10 Continuous service life
The continuous service life of ultra-violet disinfection unit shall not be less
than 5,000 h or the nominal value of manufacturer. During this time, the
effective dose of ultra-violet, disinfection effect and effluent quality of
ultra-violet disinfection unit shall meet requirements.
6 Test method
6.1 Test conditions
6.2 Appearance
Visual inspection.
6.3 Material
6.3.1 Carry out the detection according to the method specified in GB/T
17219.
6.3.2 The metal surface contact with water in the ultra-violet disinfection unit
shall be tested according to GB 2423.17.The test period is 96 h. The
sampling size 100 mm × 100 mm. Before the test, the surface shall be
cleaned and degreased. After the test, check the surface condition.
6.3.3 Light up the ultra-violet lamp for 24 h in the absence of water of
ultra-violet disinfection unit. Turn off the ultra-violet lamp and visually inspect
whether the structural material is deformed, damaged or softened. And carry
out the test according to 6.4.2 and the provisions of GB/T 17219.
6.4 Structure
6.4.2.3 Cycle pressure test
Carry out the cycle pressure test of ultra-violet disinfection unit according to
the following requirements.
6.5 Health and safety
Measure according to the method specified in GB/T 17219.
6.6 Effective dose of ultra-violet
Carry out the test according to the method specified in GB/T 19857.
6.7 Disinfection effect
6.7.1 Measure the disinfection effect of ultra-violet disinfection unit
according to the method specified in 4.2 of Ministry of Health, "Drinking Water
Disinfectant and Disinfection Equipment, Health and Safety Evaluation" (Trial)
(2001).
6.8 Effluent quality
Measure according to the method specified in GB/T 5750.
6.9 Electrical safety
Carry out the test according to the method specified in GB 4706.1.
6.10 Continuous service life
Carry out the draining test of ultra-violet disinfection unit according to the
nominal water flow of manufacturer. Carry out the timing till 5,000 h or the
nominal continuous service life of manufacturer (the larger value shall be
selected). Measure the effective dose of ultra-violet, disinfection effect and
effluent quality at this time according to the methods specified in 6.5, 6.6, 6.7.
7 Inspection rules
7.1 Inspection classification
The inspection consists of exit-factory inspection and type inspection.
7.2 Exit-factory inspection
7.2.4 The total number of effluent colonies and electrical safety projects in
the exit-factory inspection are fatal defects. As long as a piece fails to meet
the requirements, this batch of products shall be determined as unqualified.
7.3.4 The sample for type inspection shall be randomly extracted from the
exit-factory inspection qualified products. See Table 4 for sampling plan.
8 Marks, packaging, transport, storage
8.1 Marks
A nameplate shall be clearly marked on ultra-violet disinfection unit. The
following information shall be clearly marked on the nameplate.
8.2 Packaging
8.2.1 The packaging and storage marks shall conform to the provisions of
GB/T 191.
8.2.2 The packaging for the ultra-violet disinfection unit shall comply with
the provisions of GB/T 1019.
8.2.3 The outer surface of the box shall at least clearly indicate the following
information.
8.2.4 The following technical documents shall be attached to the packing
box.
8.3 Transport
The ultra-violet disinfection unit shall be fixed during the transport process to
avoid collision, fall, rain and moisture; shall not be pressed or inverted; shall
not be mixed with toxic and hazardous materials.
8.4 Storage
The ultra-violet disinfection unit shall be stored in a dry, ventilated place
without toxic or harmful items; shall not be pressed or inverted; shall avoid
long-term direct sunlight.
......
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1019General requirements for the package of household and similar electrical appliances
- GB/T 2423.17Environmental testing - Part 2: Test methods - Test Ka: Salt mist
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB 4706.1
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