|
US$459.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0459-2025: Implants for surgery - Acrylic resin cements
Status: Valid YY 0459: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0459-2025 | English | 459 |
Add to Cart
|
4 days [Need to translate]
|
Implants for surgery - Acrylic resin cements
| Valid |
YY 0459-2025
|
| YY 0459-2003 | English | 394 |
Add to Cart
|
3 days [Need to translate]
|
Implants for surgery. Acrylic resin cements
| Valid |
YY 0459-2003
|
PDF similar to YY 0459-2025
Basic data | Standard ID | YY 0459-2025 (YY0459-2025) | | Description (Translated English) | Implants for surgery - Acrylic resin cements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 22,232 | | Date of Issue | 2025-02-26 | | Date of Implementation | 2028-03-01 | | Older Standard (superseded by this standard) | YY 0459-2003 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the physical, mechanical, marking and packaging requirements for radiopaque and radiopaque cured polymeric resin bone cements mainly based on polymethacrylate. The two types of bone cements are used in syringes or in dough form, respectively, and are mainly used for internal fixation of prostheses in artificial joint replacement surgery. Bone cement is provided in sets of measured sterile powders and sterile liquids, suitable for mixing at the time of implantation. This standard does not involve the hazards of bone cement to patients or bone cement users when using bone cement. All requirements and all tests apply only to sterile products. | YY 0459-2025: Implants for surgery - Acrylic resin cements---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.
ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0459-2003
Surgical Implants Acrylic Bone Cement
(ISO 5833.2002,MOD)
Released on 2025-02-26
2028-03-01 Implementation
The State Drug Administration issued
Table of contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Liquid components 1
5 Powder component 1
6 Powder-liquid mixture for syringe use 2
7 Powder-liquid mixture for use in dough form 2
8 Set and polymerized bone cement 3
9 Packaging 3
10 Sign 3
Appendix A (Normative) Determination of stability of liquid components 4
Appendix B (Normative) Determination of dough time of bone cement powder-liquid mixture used in dough form 5
Appendix C (Normative) Determination of maximum temperature and setting time of powder-liquid mixture 6
Appendix D (normative) Determination of the extrusion rate of bone cement powder-liquid mixture used in dough form 9
Appendix E (Normative) Determination of compressive strength of bone cement 11
Appendix F (Normative) Determination of flexural modulus and flexural strength of bone cement 14
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces YY 0459-2003 "Acrylic Resin Bone Cement for Surgical Implants". Compared with YY 0459-2003,
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed the requirements for "precision of contents" (see 4.3, 3.3 of the.2003 edition);
--- Changed the "average value" of "maximum temperature" in Table 1 from "90" to "≤90" (see Table 1 in Chapter 6,.2003 Edition
Table 1 in Chapter 5);
--- Changed the test steps of "Determination of stability of liquid components" (see A.4.2, A.4.4, A.4.2, A.4.4 of the.2003 edition);
--- Changed the test conditions for "Determination of dough time of bone cement powder-liquid mixture used in dough form" (see B.3,.2003 edition
B.3);
--- Changed the test procedure of "Determination of dough time of bone cement powder-liquid mixture used in dough form" (see B.4.1,.2003
B.4.1 of the version);
--- Changed the test conditions of "Determination of maximum temperature and setting time of powder-liquid mixture" (see C.3, C.3 of the.2003 edition);
--- Changed the test steps of "Determination of compressive strength of bone cement" (see E.4.6, E.4.8, E.4.6, E.4.9 of the.2003 edition), deleted
"The cylinder is kept at a constant temperature of (23 ± 1) °C" (see E.4.8 of the.2003 edition);
--- Changed the appropriate materials for preparing molds in the determination of flexural modulus and flexural strength of bone cement (see F.2.3,.2003 edition
F.2.3);
--- Changed the test procedure of “Determination of flexural modulus and flexural strength of bone cement” (see F.4.4, F.4.4 of the.2003 edition).
This document is modified from ISO 5833.2002 “Acrylic resin bone cements for surgical implants”.
This document has made the following structural adjustments compared to ISO 5833.2002.
--- Added "Normative references" (see Chapter 2), and the numbers of other clauses were adjusted accordingly.
The technical differences between this document and ISO 5833-2.2002 and their reasons are as follows.
--- Changed the requirement of "Precision of contents" (see 4.3, 3.3 of ISO 5833-2.2002) to be consistent with 10.1b);
--- Changed the "average value" of "maximum temperature" in Table 1 (see Table 1 in Chapter 6, Table 1 in Chapter 5 of ISO 5833-2.2002).
The average maximum temperature of cement is different, so it is changed from "90" to "≤90" for a more accurate description and easier to understand;
--- Changed the test procedure of "Determination of stability of liquid components" (see A.4.2, A.4.4, ISO 5833-2.2002 A.4.2,
A.4.4), refer to the Pharmacopoeia of the People's Republic of China 2020 edition Part IV 0633 Viscosity Determination Method Second Method Ubbelohde Capillary Viscosity
Meter determination method;
--- Changed the test conditions for "Determination of dough time of bone cement powder-liquid mixture used in dough form" (see B.3, ISO 5833-
B.3 of 2.2002) specifies the relative humidity range in the test conditions;
--- Changed the test procedure of "Determination of dough time of bone cement powder-liquid mixture used in dough form" (see B.4.1,
ISO 5833-2.2002 B.4.1), because the existing methods of using bone cement are "adding powder to liquid" and "adding liquid to powder".
There are two types of "body";
--- Changed the test conditions for "Determination of maximum temperature and setting time of powder-liquid mixture" (see C.3, ISO 5833-2.2002
C.3) specifies the relative humidity range in the test conditions;
--- Changed the test procedure of "Determination of compressive strength of bone cement" (see E.4.6, E.4.8, E.4.6, E.4.8 of ISO 5833-2.2002)
E.4.9), deleted "the cylinder is kept at a constant temperature of (23 ± 1) °C" (see E.4.8 of ISO 5833-2.2002) to improve the test steps.
Steps to ensure the accuracy of the results;
--- Changed the appropriate materials for preparing molds for the determination of flexural modulus and flexural strength of bone cement (see F.2.3, ISO 5833-2.2002
F.2.3) to adapt to existing technical conditions;
--- Changed the test procedure of "Determination of flexural modulus and flexural strength of bone cement" (see F.4.4, ISO 5833-2.2002
F.4.4) to improve the test steps and ensure the accuracy of the results.
The following editorial changes were made to this document.
--- Added a note to explain that other non-artificial joint replacement bone cements can refer to this document (see Chapter 1, ISO 5833-2.
2002, Chapter 1);
--- Deleted "Appendix D" in "Solidification characteristics, test methods and requirements" (see 6.1 of ISO 5833-2.2002).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110).
The previous versions of this document and the documents it replaces are as follows.
---First issued in.2003 as YY 0459-2003;
---This is the first revision.
Surgical Implants Acrylic Bone Cement
1 Scope
This document specifies the materials for radiopaque and radiolucent curing polymeric resin bone cements, primarily based on polymethacrylates.
The two types of bone cement are available in syringes or in dough form and are mainly used in artificial joint replacement.
Internal fixation of prostheses during surgery. Bone cement is supplied in sets of sterile powder and sterile liquid in measured quantities, suitable for mixing at the time of implantation.
This document does not address the risks to patients or users of bone cement when using bone cement.
All requirements and all tests apply only to sterile products.
Note. For other bone cements not used for artificial joint replacement, refer to this document.
2 Normative references
This document has no normative references.
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Unit of cement
One package or bottle of sterile powder and one package or bottle of sterile liquid.
NOTE. For bone cements that are supplied with a radiopaque agent alone, the individual sets of bone cement also contain a packet or bottle of measured radiopaque powder component.
4 Liquid components
4.1 Appearance
When examined with normal or corrected vision, the fluid should be free of particles and other impurities.
4.2 Stability
When tested according to the method described in Appendix A, the increase in the flow time of the liquid sample should not exceed 10%.
4.3 Precision of contents
When the measurement accuracy is ±0.1 mL or ±0.1 g, the volume or mass of each liquid component in the 5 sets of bone cement should not exceed the nominal value of the package.
±5% of the value [see 10.1b)].
5 Powder components
5.1 Overview
The powder components include polymer particles, initiators, and, in the case of radiopaque bone cement, radiopaque agents.
In the following cases, the radiopaque agent is provided separately.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0459-2025_English be delivered?Answer: Upon your order, we will start to translate YY 0459-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY 0459-2025_English with my colleagues?Answer: Yes. The purchased PDF of YY 0459-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. Question 5: Should I purchase the latest version YY 0459-2025?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0459-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.
|