YY 0060-2018Hot compress sticker(bag) (English PDF)

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);

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 document. 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.