Valid

YY/T 1745-2021Automated feces analyzer (English PDF)

自动粪便分析仪

Preview PDF

This is a limited preview

Buy now to download the full PDF (17 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1745-2021 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

September 6, 2021

Implementation date

September 1, 2022

Scope

YY/T 1745-2021 is the English-translated version of 自动粪便分析仪.

YY/T 1745-2021 is the Chinese pharmaceutical industry standard for the automated faeces analyser, the instrument that examines a stool specimen for its physical characteristics and its formed elements and records images of them.

It gives the terms and definitions, the requirements and the test methods, and the rules for marks, labels, instructions, packaging, transport and storage, covering the agreement of the results with microscopy, the carry-over between specimens, the repeatability, the quality of the images, the throughput and the safety of a machine that handles infectious material. Issued on 6 September 2021, it has applied since 1 September 2022.

Found what you need?

Document preview — YY/T 1745-2021

National Standard of the People's Republic of China

Classification: C 44

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the terms and definitions, requirements, test methods, signs, labels and instructions, packaging, transportation and storage of automatic stool analyzers store and so on.

This standard applies to the automatic or manual analysis of the physical indicators, tangible components, etc. of human fecal specimens, and provides the tangible components Automatic stool analyzer with live images and other relevant information.

2 Normative references

The following documents are essential 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 191 Graphical signs of packaging, storage and transportation

GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Laboratory use for analysis and other purposes Particular requirements for automatic and semi-automatic equipment

GB 4943.1 Information Technology Equipment Safety Part 1: General Requirements

GB 9254 Radio Disturbance Limits and Measurement Methods for Information Technology Equipment

GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances

GB 17625.1 Electromagnetic Compatibility Limits Harmonic Current Emission Limits (Each Phase Input Current of Equipment<=16A)

GB/T 18268.1-2010 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB/T 18268.26-2010 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26: Special Requirements Looking for in vitro diagnostic (IVD) medical equipment

GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3: In vitro diagnostic instruments for professional use

YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1: General Requirements

YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment specific requirements

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 Automated feces analyzer

It is used for the detection of human fecal samples, which can automatically or manually analyze the physical indicators, formed components, etc. in the feces, and provide the formed components. Instruments for real pictures and other relevant information.

3.2 Fecesphysicalindex

Physical indicators in stool samples, including stool color and character.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9 · GB 9254

How to Download YY/T 1745-2021

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.