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YY 0333-2010: Soft-tissue expander device
Status: Valid YY 0333: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0333-2010 | English | 259 |
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Soft-tissue expander device
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YY 0333-2010
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| YY 0333-2002 | English | 359 |
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Soft-tissue expander device
| Obsolete |
YY 0333-2002
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PDF similar to YY 0333-2010
Basic data | Standard ID | YY 0333-2010 (YY0333-2010) | | Description (Translated English) | Soft-tissue expander device | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 11,187 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Older Standard (superseded by this standard) | YY 0333-2002 | | Quoted Standard | GB/T 528-1998; GB 15811; YY 0334; YY 0647 | | Adopted Standard | ASTM F1441-2003, NEQ | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to single-use rechargeable into salt water, or for use in surgical implants removed within 6 months after the soft tissue expander. This standard applies only to the elastic casing made of soft tissue expander, not including any other standard production custom soft tissue expander. For the "expander/breast" combo devices, this standard applies (see 4. 3). | YY 0333-2010: Soft-tissue expander device---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.
Soft-tissue expander device
ICS 11.040.30
C31
People's Republic of China pharmaceutical industry standards
Replacing YY 0333-2002
Soft tissue expander
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard and ASTMF1441-03 "soft tissue expander standards," the non-equivalent.
This standard replaces YY 0333-2002 "soft tissue expander."
The main technical differences between this standard and YY 0333-2002 that.
--- Increased soft tissue expander classification;
--- Seam into critical and non-critical seams seams, increased non-critical joint connection strength requirements;
--- Increasing the injection seat specifications;
--- Increasing the pipeline to extend the joint strength test;
--- Increased volume requirements, size, fixed position, targeting methods;
--- Removes the requirement housing physical and mechanical properties of elongation;
--- Cancel the inspection rules.
This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This standard drafting units. Shandong Medical Devices Product Quality Inspection Center.
The main drafters of this standard. Song Jinzai, Wu Ping, Zhang Limei, Wang red.
Introduction
Soft tissue expander surgery is expected to be placed in the muscles or soft tissues of the instrument.
Soft tissue expander is expected at the implantation site filling, so that the pressure is sufficient to expand the implant site soft tissue. This expansion may also occur in the soft tissue
Weaving the stent envelope or housing, because the expansion may be filling in normal use exceeds its nominal volume, which is also considered to be reasonable
of. To make use of leak or collapse of the possible minimum, this standard includes structural materials, adhesive bonding or physical area and the connecting member
Energy requirements.
When using a hypodermic needle through the soft tissue expander injection seat expansion is completed, in order to achieve proper expansion, generally need to occasionally
Its multiple injections. Accordingly, the standard include multiple injections of anti-needle injection seat leakage requirements.
Soft tissue expander covered by this standard in order to achieve its intended purpose, which is expected to have many shapes and sizes, types and design of its junction
Materials of construction will be a lot. Thus, the standard includes requirements for the label, including the expansion given the features and functionality of the appropriate use and other
information.
Methodology and indicators for tear test without making the appropriate consideration, so the standard is not the final product made tear requirements.
The performance requirements for the preparation of a gap measurements on the sample, the instrument due to cracks caused by narrow and severely damaged. Recommended by the
GB/T 529 constituting the soft tissue expander raw materials used tear tests, test results and evaluate whether the supplier material specification
Consistent.
This standard includes technology infrastructure based on the requirements of the present stage of science. These requirements have been proven to ensure a soft tissue expander assembly
Have appropriate safety and efficacy is crucial.
This standard does not apply to equipment production expectations related science and technology has brought restrictions. If there are new information, or based on previous scientific
Where relevant scientific and technical equipment level changes, we need to consider the revision of this standard.
Soft tissue expander
1 Scope
This standard applies to single-use can be filled with brine, used in surgery or post-implant soft tissue expander removed within 6 months.
This standard applies only to soft tissue expander housing is made of an elastic, do not include any other standard production of customized soft tissue expansion
Zhang is.
For the "expander/breast" combination instrument, this standard applies (see 4.3).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 528-1998 Determination of vulcanized rubber or thermoplastic rubber tensile stress-strain properties
GB 15811-time use of sterile needles
YY 0334 silicone rubber surgical implants - General requirements
YY 0647 requirements for active surgical implants breast implants
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Injection seat injectionport
This seat injection to the charge or reduced from the variable volume instruments.
3.1.1
Split seat remoteport
Away from the housing through the injection pipe and connected to the housing base.
3.1.2
One seat self-contained (integrated) port
Even with the instrument housing as one of the injection units.
3.2
Injection surface injectionsurface
Recommended by the manufacturer for the injection seat piercing needle injection to increase or reduce the volume of regional instruments.
3.3
Acupuncture stopper needlestop
Injection seat for limiting the hypodermic needle penetrates the injection holder member.
3.4
Silicone rubber siliconeelastomer
Containing silicone polymer and fumed silica reinforcing filler cured elastomer.
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