納米技術-磁性納米材料-第2部分:核酸提取用納米結構磁性微球特性和測量方法規范

2021年10月，國際標準化組織官方網站發布了第一個生物納米磁珠國際標準：ISO/TS 19807-2:2021納米技術-磁性納米材料-第2部分：核酸提取用納米結構磁珠特性和測量方法規范，該標準對規范和推動磁珠在生物醫學領域的應用具有重要的意義。

ISO - TS 19807-2

Nanotechnologies — Magnetic nanomaterials — Part 2: Specification of characteristics and measurement methods for nanostructured magnetic beads for nucleic acid extraction

該專利的核心部分如下：

3   Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/TS 80004-1, ISO/TS 80004-6 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
bead mass concentration 粒子質量濃度
ratio of the mass of magnetic beads (3.6) to the total volume of a magnetic beads sample in suspension or powder form
3.2
bead size 粒子尺寸
effective outer diameter of a magnetic bead (3.6) determined by using the specified measurement method
3.3
bead size distribution 粒子尺寸分布
distribution of beads as a function of bead size (3.2)
Note 1 to entry: Bead size distribution may be expressed as cumulative distribution or a distribution density (distribution of the fraction of beads in a size class, divided by the width of that class).
3.4
dispersing medium 分散介質
liquid in which magnetic beads (3.6) are suspended
3.5
initial magnetic mass susceptibility 磁性粒子矯頑力
differential ratio of the change in mass magnetization of a material to the amplitude of a magnetic field change at a sufficiently small absolute magnetic field
Note 1 to entry: A magnetic beads (3.6) sample is assumed to be magnetically isotropic and its initial magnetic mass susceptibility is indicated as a scalar.
3.6
magnetic bead 磁珠
small round piece containing a large number of magnetic nanoparticles which can be superparamagnetic and are immobilized within a non-magnetic matrix
Note 1 to entry: The size range of magnetic beads for DNA extraction spans from a few tens of nanometres to several micrometres.
3.7
mass-specific surface area 單位質量比表面積
absolute surface area of the sample divided by sample mass
[SOURCE:ISO/TS 80004-6:2021, 4.6.1, modified — Note 1 to entry has been removed.]
3.8
nucleic acid 核酸
macromolecule that is the medium for genetic information or acts as an agent in expressing the information
Note 1 to entry: There are two types of nucleic acid, DNA and RNA.
[SOURCE:ISO 17822:2020, 3.32]
3.9
nucleic acid binding capacity 核酸結合容量
mass of nucleic acid (3.8) bound to the surfaces of magnetic beads (3.6) per unit mass of the magnetic beads under specified conditions
3.10
operational time 操作時間
maximum time after the start of the extraction process where the suspension of magnetic beads (3.6) is ready for use to extract nucleic acid (3.8)
Note 1 to entry: the operational time is usually recommended by the manufacturer.
3.11
remanent mass magnetization 剩磁
value of the mass magnetization remaining in a magnetized body when, in the absence of a self-demagnetizing field, the applied magnetic field strength is brought to zero
[SOURCE:IEC 60050:1990, 221-02-40, modified — "magnetization" has been changed to "mass magnetization".]
3.12
saturation mass magnetization 飽和磁強度
limiting value of the mass magnetization of a liquid or dried sample with increasing applied magnetic field strength
Note 1 to entry: The saturation mass magnetization of magnetic beads (3.6) is indicated for the dried matter of a bead suspension sample or for the dried sample in the case of beads in powder form.
3.13
shelf life 貨架期
recommended time period by manufacturer during which a product (suspension or powder) can be stored, throughout which the defined quality of specified characteristics of the product remains acceptable under expected (or specified) conditions of distribution, storage, display and usage
Note 1 to entry: Defined characteristics should be measured after fixed time intervals.
[SOURCE:ISO/TS 19807-1:2019, 3.37, modified — the manufacturer has been specified and the powder product has been added.]
3.14
surface functional group density 表面功能基團密度
mass of surface functional groups per unit mass of magnetic beads (3.6)
3.15
surface functional group type 表面功能基團類型
chemical type of substituents or moieties on the surface of magnetic beads (3.6) that are responsible for a specific chemical reaction

簡單來說，就是這個專利規范了磁性納米粒子的一些標準特征和這些特征的檢測方法。