Valid

YY/T 1740.3-2024Clinical mass spectrometer - Part 3: Inductively coupled plasma mass spectrometer (English PDF)

医用质谱仪第3部分：电感耦合等离子体质谱仪

Preview PDF

This is a limited preview

Buy now to download the full PDF (24 pages)

Need quotation for your management?

Get a formal quotation for YY/T 1740.3-2024 in 30 minutes.

Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

February 7, 2024

Implementation date

March 1, 2025

Scope

YY/T 1740.3-2024 is the English-translated version of 医用质谱仪第3部分：电感耦合等离子体质谱仪.

YY/T 1740.3-2024 is the Chinese standard "Clinical mass spectrometer - Part 3: Inductively coupled plasma mass spectrometer". Its scope clause reads: This document specifies the requirements, labeling, instructions for use, packaging, transportation and storage of medical inductively coupled plasma mass spectrometers.

Appropriate test method. This document applies to medical inductively coupled plasma mass spectrometer (ICP-MS), which is mainly used to analyze inorganic elements in human samples.

Elements such as potassium, calcium, zinc, iodine, etc. Its clauses include terms and definitions.

Found what you need?

Document preview — YY/T 1740.3-2024

National Standard of the People's Republic of China

ICS: 11.100.10
Classification: C44

Issued by: National Medical Products Administration

Foreword
Introduction
1 Scope
2 Normative references

1 Scope

This document specifies the requirements, labeling, instructions for use, packaging, transportation and storage of medical inductively coupled plasma mass spectrometers.

Appropriate test method.

This document applies to medical inductively coupled plasma mass spectrometer (ICP-MS), which is mainly used to analyze inorganic elements in human samples.

Elements such as potassium, calcium, zinc, iodine, etc.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

GB/T 191 Pictorial markings for 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.Electrical equipment for laboratory analysis and other purposes

Special requirements for automatic and semi-automatic equipment

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

GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements

GB/T 18268.26 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 26.Special requirements for in vitro

Diagnostic (IVD) Medical Devices

GB/T 29791.3 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic instruments

YY 0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101.In vitro diagnostic (IVD) medical equipment

Special requirements for

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Mass range

A range between the lower and upper limits of the mass-to-charge ratio that a mass spectrometer can measure.

[Source. GB/T 6041-2020, 2.4, modified]

Note. The unit is expressed in u.

3.2 Mass resolution

Mass resolution is expressed as the peak width at 10% of the mass peak height of an element.

[Source. JJF1159-2006, 3.2, modified]

Note. The unit is expressed in u.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9

How to Download YY/T 1740.3-2024

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.