YY/T 1235-2014Rubella IgG/IgM antibody detection kit (English PDF)
风疹病毒IgG/IgM抗体检测试剂（盒）
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1235-2014 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1235-2014 is the English-translated version of 风疹病毒IgG/IgM抗体检测试剂（盒）.
YY/T 1235-2014 is the Chinese pharmaceutical industry standard for the kit that detects IgG and IgM antibody to rubella virus.
It specifies the requirements, the test methods, the marking, the labelling, the instruction manual and the rules for packaging, transport and storage, covering the appearance, the agreement with the reference materials for positive and negative sera, the detection limit, the specificity, the repeatability and the stability of the kit. Issued on 17 June 2014, it has applied since 1 July 2015.
Found what you need?
Document preview — YY/T 1235-2014
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Requirements4
- 4 Test methods6
- 5 Marking, labeling, and instructions7
- 6 Packaging, transportation, and storage9
- References10
Foreword
This Standard was drafted according to the rules given by GB/T 1.1-2009.
1 Scope
This Standard specifies the requirements, test methods, marking, labeling, instructions manual, packaging, transportation, and storage of rubella IgG / IgM antibody detection kit (hereinafter referred to as "reagents (kit)").
This Standard applies to the qualitative detection of rubella IgG / IgM antibody in human serum/plasma detection kit (enzyme-linked immunosorbent assay method), rubella IgG / IgM antibody detection kit (chemiluminescence method), rubella IgG / IgM antibody detection kit (immunofluorescence method), rubella IgG / IgM antibody detection kit (Immunoblotting method), etc.
2 Normative references
The provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Standard.
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements
3 Requirements
3.1 Technical requirements for rubella IgG antibody detection kit
3.1.1 Appearance
Appearance shall meet the following conditions. […]
3.1.3 Specificity (negative coincidence rate)
USE rubella IgG antibody detection reagents to test national negative reference materials or standardized negative reference materials. The results shall meet the requirements.
3.1.4 Repeatability (precision)
3.1.4.1 USE rubella IgG antibody detection reagents to test repeatability reference materials. The coefficient of variation (CV) of within-batch precision shall not exceed 15.0%.
3.2 Technical requirements for rubella IgM antibody detection kit
3.2.1 Appearance
Appearance shall meet the following conditions. […]
3.2.4 Repeatability (precision)
3.2.4.1 USE rubella IgM antibody detection reagents to test repeatability reference materials, the coefficient of variation (CV) of within-batch precision shall not exceed 15.0%.
3.2.5 Detection limit
USE rubella IgM antibody detection reagents to test national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit. The results shall meet the requirements.
4 Test methods
4.1 Test method of rubella IgG antibody detection kit
4.1.1 Appearance
INSPECT the appearance visually in natural light. The results shall meet the requirements of 3.1.1.
4.1.5 Detection limit
USE national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit to detect once respectively. OPERATE according to instructions. The results shall meet requirements of 3.1.5.
4.2 Test method of rubella IgM antibody detection kit
4.2.1 Appearance
INSPECT the appearance visually in natural light. The results shall meet the requirements of 3.2.1.
4.2.4 Repeatability (precision)
USE repeatability reference materials to detect for 10 times. OPERATE according to instructions. The results shall meet requirements of 3.2.4.
4.2.5 Detection limit
USE national reference materials of minimum detection limit OR standardized reference materials of minimum detection limit to detect once respectively. OPERATE according to instructions. The results shall meet requirements of 3.2.5.
5 Marking, labeling, and instructions
5.1 Marking and labeling of reagents' (kit) outer packing
It shall include at least the following contents. […]
5.2 Marking and labeling of reagents' (kit) each component's packing
It shall include at least the following contents. […]
5.3 Instructions manual of reagents (kit)
It shall include at least the following contents. […]
6 Packaging, transportation, and storage
6.1 Packaging
Pictorial markings for packaging, transportation, and storage shall comply with the specifications of YY/T 0466.1. Reagents (kit) shall be packaged according to the requirements of manufacturer.
6.2 Transportation
Reagents (kit) shall be transported according to the requirements of manufacturer. […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1235-2014
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2023 — Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Secure payment via Stripe
Payments accepted
YY/T 1235-2014
$125.00