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YY 0060-2018: Hot compress sticker (bag)
Status: Valid YY 0060: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0060-2018 | English | 239 |
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3 days [Need to translate]
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Hot compress sticker (bag)
| Valid |
YY 0060-2018
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| YY 0060-1991 | English | 319 |
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Hot compressive therapy
| Obsolete |
YY 0060-1991
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PDF similar to YY 0060-2018
Basic data | Standard ID | YY 0060-2018 (YY0060-2018) | | Description (Translated English) | Hot compress sticker (bag) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 12,144 | | Date of Issue | 2018-11-07 | | Date of Implementation | 2020-05-01 | | Older Standard (superseded by this standard) | YY 0060-1991 | | Quoted Standard | GB/T 16886.1-2011; GB/T 19789-2005; GB/T 26253-2010 | | Regulation (derived from) | Announcement No. 87 of 2018 by the State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, classification, requirements, and test methods for thermal application (bags). This standard is applicable to the main material components (iron powder, water, activated carbon, salt, etc., and does not contain any pharmaceutical ingredients), put into the inner bag seal according to a certain proportion, using the principle of temperature rise and heating of iron powder oxidation, through heat conduction A method of applying adjunctive treatment to a patient. For multi-functional application products (such as magnetic therapy, far-infrared and other functions), other functions, such as corresponding national standards and / or industry standards, should also meet the requirements of other relevant standards. This standard does not apply to: chemical substances, Chinese herbal medicines (or natural plants) and their extracts, etc., containing ingredients to play pharmacological, immunological or metabolic applications; containing chemical ingredients, Chinese herbal medicines (or natural Plant) and | YY 0060-2018: Hot compress sticker (bag)---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Hot compress sticker (bag)
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0060-1991
Hot application (bag)
Published on.2018-11-07
2020-05-01 implementation
State Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and composition 2
5 Requirements 2
6 Test method 4
Appendix A (Normative Appendix) Temperature Test Method 7
Foreword
In this standard, 5.6 is a recommended clause and the rest are mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0060-1991 "Hot Shi Ling". Compared with YY 0060-1991, this standard is mainly composed of editorial modifications.
The changes are as follows.
--- Clarified the scope of application of this standard and the product categories that are not applicable (see paragraphs 2 and 3 of Chapter 1);
--- Removed clinical indications (third paragraph of Chapter 1 of the.1991 edition);
---Add, replace and delete relevant normative references to ensure the current validity of the cited standards (see Chapter 2,.1991 Edition)
Chapter 2);
--- Increased the definition of thermal application (bag) (see 3.1);
--- Revised the definition of "heating time" in the term (see 3.3, 3.2 of the.1991 edition);
--- Increased the content of classification, main material composition and structural composition (see 4.1, 4.2, 4.3);
--- Deleted the contents of "The design and documentation of the heat application should meet the requirements of this standard and approved according to the prescribed procedures" (1991)
Version of the year 4.1);
--- Added "the size of the inner bag and the adhesive surface should conform to the manufacturer's regulations", and deleted the specific values of the length and width of the size, revised
Dimensional error requirements (see 5.1, 4.7 of the.1991 edition);
--- Revised the requirements and test methods for the tightness of the outer packaging (see 5.3, 6.3,.1991, 4.3, 5.2);
--- Increased the requirement for the inner bag to resist falling (see 5.4);
--- Revised the requirements and test methods for the strength of the bag (see 5.5, 6.5,.1991, 4.4, 4.5, 5.3.1, 5.4);
--- Revised the requirements and test methods for the airtightness of the outer bag of the heat application (bag) (see 5.6, 6.6,.1991, 4.9, Table 3, 5.6);
--- Increased the adhesive performance requirements and test methods of the pasted part of the adhesive heat application (bag) (see 5.7, 6.7);
---Modified the maximum temperature, temperature rise time and temperature guarantee time requirements of temperature characteristics (see 5.8.1, 5.8.2, 5.8.4,.1991)
Table 1 of the annual edition and test methods for temperature characteristics (see Appendix A, 5.5 of.1991 edition);
--- Removed the safety requirements of the main raw materials (4.8 of the.1991 edition);
--- Increased biocompatibility requirements and test methods for materials intended to come into direct contact with human skin (see 5.9, 6.9);
--- Increase the temperature performance requirements and test methods for products in the near-term period (see 5.10, 6.10);
--- Added the relevant provisions of the manual (see 5.11, 6.11);
--- Revised the temperature performance test method and gave a specific description in the informative appendix (see Appendix A,.1991 edition 5.5);
--- Removed the relevant content of the inspection rules (Chapter 6 of the.1991 edition);
--- Removed the relevant content of marking, packaging, transportation and storage (Chapter 7 of the.1991 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Equipment Standardization Technical Committee Physical Therapy Equipment Subcommittee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Device Technology Evaluation Center.
The main drafters of this standard. Qi Lijing, Qiao Jiaqi, Zhang Haiming, Zhang Wei, Qian Xuebo.
The previous versions of the standards replaced by this standard are.
---YY 0060-1991.
Hot application (bag)
1 Scope
This standard specifies the terms and definitions, classification, requirements, and test methods for thermal application (bags).
This standard applies to the main material components (iron powder, water, activated carbon, salt, etc., and does not contain any pharmaceutical ingredients), put in a certain proportion
The inner bag is sealed, and the application method of assisting treatment of the patient by means of heat conduction is utilized by the principle of temperature rise and heat generation by oxidation of iron powder. Correct
For multi-functional application products (such as magnetic therapy, far-infrared, etc.), other functions, such as corresponding national standards and/or industry standards, should also
Meet the requirements of other relevant standards.
This standard does not apply to.
--- Contains chemical ingredients, Chinese medicinal materials (or natural plants) and their extracts, etc., containing ingredients to play pharmacology, immunology or metabolism
Applied products;
--- Contains chemical ingredients, Chinese medicinal materials (or natural plants) and their extracts, etc., can not prove to not play pharmacology, immunology or metabolism
The application of the product.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
GB/T 19789-2005 Packaging materials plastic film and sheet oxygen permeability test coulometric test
GB/T 26253-2010 Determination of water vapor transmission rate of plastic films and sheets - Infrared detector method (ISO 15106-2.2003,
MOD)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
The main material components (iron powder, water, activated carbon, salt, etc., and do not contain any pharmaceutical ingredients), sealed in a certain proportion into the inner bag, use
The principle of heating and heating of iron powder oxidation, and the application of auxiliary treatment to patients through heat conduction.
3.2
Maximum temperature maximumtemperature
The highest temperature value measured by the heat application (bag) from the beginning to the end of the heat (see Figure 1).
3.3
Heating time temperaturerisetime
The heat application (bag) starts from the time when the outer bag is opened to oxidize and heat up to 40 ° C (see Figure 1).
3.4
Duration timeofduration
The total value of the holding time of the heat application (bag) heating temperature above 40 ° C (see Figure 1).
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