Standards Development

Scope

Standardization in the field of laboratory design including site selection, design of internal layout of space and services with the objective to provide functional, safe, energy efficient and sustainable laboratories taking into account environmental impact, the practical division of experimental and support areas and layouts plus model selection of laboratory furniture.

It includes standardization of apparatus and devices for personal safety aspects that are an integral part of the laboratory. Design of devices and apparatus for experiment purposes covered by ISO/TC 48 as well as design of measuring instruments are excluded from the scope.

Excluded:

• ISO/TC 48 (laboratory equipment);

• ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems);

• CASCO;

• IEC/TC 66 (Safety of measuring, control and laboratory equipment);

• ISO/TC 209 (Clean rooms). Once the new TC is established, liaisons with other relevant ISO technical committees will be established, including:

• ISO/TC 48 (laboratory equipment);

• ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems);

• CASCO;

• ISO/TC 136 (Furniture);

• ISO TC 307 (Blockchain and distributed ledger technologies);

• ISO/TC 159 (Ergonomics);

as well as relevant IEC technical committees:

• IEC/TC 64 (Electrical installations and protection against electric shock);

• IEC/TC 81 (Lightning protection);

• IEC/TC 85 (Measuring equipment for electrical and electromagnetic quantities);

• IEC/TC 45 (Nuclear instrumentation);

• IEC/TC 62 (Electrical equipment in medical practice);

• IEC/TC 65 (Industrial-process measurement, control and automation);

• IEC/TC 76 (Optical radiation safety and laser equipment);

• IEC/TC 104 (Environmental conditions, classification and methods of test);

• and ISO/IEC JTC 1 (Information technology).

The proposed TC will not pursue subjects within the scope of other TCs including but not limited to ISO and IEC TCs listed above.

Note: the proposed TC will help laboratory design industry to address a wide range of global issues. Outbreaks of zoonotic disease like Avian Influenza (H5N1), Middle East Respiratory Syndrome (MERS), Ebola virus, Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and Coronavirus (COVID-19) has highlighted the worldwide lack of adequate laboratory capacity, especially in low-resource environments. This proposal should address this situation, early during the design stage, by providing a standardised approach on laboratory function, health and safety, energy efficiency, environmental impact and regulatory compliance issues.

Purpose

Purpose and justification for the proposal.

(The purpose and justification for the creation of a new technical committee shall be made clear and the need for standardization in this field shall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC Directives, Part 1 contains a menu of suggestions or ideas for possible documentation to support and purpose and justification of proposals. Proposers should consider these suggestions, but they are not limited to them, nor are they required to comply strictly with them. What is most important is that proposers develop and provide purpose and justification information that is most relevant to their proposals and that makes a substantial business case for the market relevance and the need for their proposals. Thorough, well-developed and robust purpose and justification documentation will lead to more informed consideration of proposals and ultimately their possible success in the ISO IEC system.)

The rationale for setting up laboratory design TC is as follows:

1. laboratories serve as the foundation for technological progress and product quality assurance and play a pivotal role in social and economic development. Worldwide, the laboratory construction volume is rising year by year, with trillions of USD invested into construction of new laboratories and renovation of existent ones. However, on a global scale there is no standard on design of various types of laboratories that project owners, designers, users and quality supervision authorities can refer to, resulting in a number of problems in laboratory construction worldwide;

2. lack of systematic laboratory design standards is the fundamental cause of frequent occurrence of laboratory accidents impacting laboratory safety and occupants’ health, some of which may also seriously jeopardize public health;

3. currently there are no internationally agreed systematic standards on laboratory design and construction. The existing ISO laboratory quality management standards ISO/IEC 17025:2017 (Section 6.3: Facilities and environmental conditions) and ISO 15189 2012 (Section 5.2 Accommodation and environmental conditions) recognizes that robust and quality outputs from laboratories are dependent on their facilities and environmental conditions but does not provide any guidance on laboratory design;

4. in recent years, there is an increasing demand from Chinese market for various types of laboratories, with hundreds billions of Chinese RMB invested each year in laboratory construction. In the process, the standards system of laboratory design and construction in China have been gradually established. First of all, the common characteristics of different regions and types of laboratories were summarized as the general requirements of laboratory design and construction. And then, the technical requirements for design and construction of different types of laboratories were specified. Now China has not only developed laboratory design standards, but also laboratory construction and acceptance standards, with the corresponding standards for laboratory environmental facilities being established along the way. China’s laboratory design standards system not only covers the general planning of laboratory, experiment procedure, layout, electrical and water supply, drainage, heating, ventilation and air purification, furniture, fire prevention, safety, energy efficiency and environmental protection. During the standards compilation, experts and scholars integrated new technologies, materials and processes proven technically and economically effective in practice into the standards, which has greatly improved the level of laboratory construction in China, and provided support to the economic and social development. By setting up the laboratory design TC, China is willing to harness its accumulated experience and work together with other ISO member countries on the development of ISO laboratory design standard, in order to benefit other countries around the world;  

5. it has been shown in many cases that, as a result of unhealthy laboratory of environment, the researchers working in laboratories developed diseases such as lung cancer, leukaemia and brain cancer. The underlying causes of these problems are the lack of laboratory design standards addressing health and safety;

6. environmental protection, energy efficiency and emissions reduction in laboratory construction will be given more prominence, addressing climate change issues and meeting sustainable development goals;

7. lack of standards on Smart laboratories that integrate facilities and instrumentation has adversely impacted the generation and utilization of quality laboratory data;

8. many national or regional standards on many aspects of laboratory design and construction exist. Developing a consistent and internationally acceptable approach taking all these into account will prove a challenging task. This TC will provide an overview of these existing standards, categorise best practices and endeavour to integrate and refer to them in a globally acceptable international standard.

The establishment of laboratory design TC will:

1. promote the development and implementation of international standards on laboratory design;

2. provide standards for the design of various types of laboratories and allow laboratory design principles and methods to be known on a global scale in order to avoid the occurrence of accidents impacting safety and health;

3. provide professional references for ensuring scientific laboratory facilities and environmental conditions, and technical support to guarantee the data reliability of research and testing laboratories;

4. provide technical requirements on laboratory environment conditions in order to minimize the adverse impact on the health of laboratory personnel and insure ttheir wellbeing;

5. provide technical requirements on environment protection in order to promote energy saving and emission reduction.