YY/T 0290.4-2022 English PDF

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YY/T 0290.4-2022: (Ophthalmic optics - Intraocular lenses - Part 4: Labeling and information)
Status: Valid

YY/T 0290.4: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0290.4-2022	199	Add to Cart	3 days	(Ophthalmic optics - Intraocular lenses - Part 4: Labeling and information)	Valid
YY 0290.4-2008	314	Add to Cart	3 days	Ophthalmic implants. Intraocular lenses. Part 4: Labeling and information	Obsolete
YY 0290.4-1997	359	Add to Cart	3 days	Intraocular Ienses. Part 4: Labeling and information	Obsolete

Similar standards

YY/T 0294.1   YY/T 0296   GA 36   YY/T 0290.5   YY 0290.8   YY/T 0290.1   

Basic data

Standard ID: YY/T 0290.4-2022 (YY/T0290.4-2022)
Description (Translated English): (Ophthalmic optics - Intraocular lenses - Part 4: Labeling and information)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C32
Word Count Estimation: 10,139
Issuing agency(ies): State Drug Administration

YY 0290.4-2008: Ophthalmic implants. Intraocular lenses. Part 4: Labeling and information

---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.
Ophthalmic implants.Intraocular lenses.Part 4. Labeling and information ICS 11.040 C40 People's Republic of China pharmaceutical industry standards YY 0290.4-2008/ISO 11979-4.2000 Replacing YY 0290.4-1997 Ophthalmic optics IOL Part 4. Labelling and information (ISO 11979-4.2000, IDT) Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued

Foreword

YY 0290 "IOL optics" is divided into nine sections. --- Part 1. Terminology; --- Part 2. Optical properties and test methods; --- Part 3. Mechanical properties and test methods; --- Part 4. Labelling and information; --- Part 5. biocompatibility; --- Part 6. Validity of the transport and stability; --- Part 8. basic requirements; --- Part 9. multifocal intraocular lens; --- Part 10. Phakic IOL; This is Part 4 YY 0290 of. This part identical with ISO 11979-4.2000 "ophthalmology intraocular lens implants - Part 4. Labelling and information." This Part replaces YY 0290.4-1997 "IOLs - Part 4. Labelling and information." This section compared with YY 0290.4-1997 main changes are as follows. --- Normative references YY 0290.1 adopt the 2008 version; --- Scope appropriately adjusted; The term --- YY 0290.4-1997 Chapter 3 presented in this release are listed in Appendix A (Informative appendix); --- YY 0290.4-1997 content in Table 1 of this standard split into Table 1, Table 2, and an increase in related projects; --- Chapter 5 of the items were part of the adjustment; Appendix A --- original content is adjusted to a standard chapter 6 in this release. Appendix A of this section is an informative annex. This standard by the National Standardization Technical Committee of medical and optical instruments and optical instruments at the Technical Committee (SAC/TC103/SC1) and focal points. This section drafted by. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this part. He Tao, Zheng, JIA Xiao Hang, Wen Yan, Mary. YY 0290.4-2008/ISO 11979-4.2000 Ophthalmic optics IOL Part 4. Labelling and information

1 Scope

YY 0290 This section specifies the content of the information provided on the requirements of intraocular lens (IOL) labeling and packaging or packaging.

2 Normative references

The following documents contain provisions which, through reference YY 0290 present, constitute provisions of this section. For dated references, Its subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage each agreement under this section Are Prescriptions can use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. YY 0290.1-2008 IOL optics - Part 1. Terminology

3 Terms and Definitions

Terms and definitions apply YY 0290 YY 0290.1 established this section. Note. Some terms and definitions in this section YY 0290.1 relevant given in Appendix A as an information appendix.

4 labels

Table 1 lists the information IOL label must contain at least, and indicate that information should be marked on which layer of packaging. Table 2 When applicable, the additional information given. Table 1 IOL information should be included on packaging No. content Label position Original packaging and/or additional packing a packaging b Remark 1 Manufacturer's name or trademark × × can add logo of the manufacturer 2 address of the manufacturer and producer × 3 product name, model and/or trade names × × 4 serial number and/or lot × × You can use the symbols prescribed YY 0466 5 "sterile" word × × b can use the symbols YY 0466 6 × standardized symbols sterilization methods can be used 7 "shall not be repeated sterilization," the words × 8 "single use" words × YY 0466 can use the symbols Expiration date (month and year, Format. YY YY MM) × You can use the symbols YY 0466 10 × × optical power Dimensionless unit of m-1; common Optometry Symbol D indicates 11 total diameter/mm × × Φ available symbol or icon representation YY 0290.4-2008/ISO 11979-4.2000 ......

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